PEN II MYLAN 3.0ML

Report

• Report Number: 2243072-2019-01036
• Event Type: Malfunction
• Date Received: May 29, 2019
• Date of Event: May 10, 2019
• Report Date: June 24, 2019
• Manufacturer: BECTON DICKINSON
• Product Code: FMI
• PMA / PMN Number: UNKNOWN
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: KY, US
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION SUMMARY: TWO (2) SAMPLES WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCH INVOLVED IN THIS COMPLAINT MEETS ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. INITIAL EVALUATION REVEALED NO VISIBLE DAMAGE TO THE PENS. THE PENS WERE TESTED FOR VOLUMETRIC DOSE ACCURACY PER IT1172. ALL DOSES WERE WITHIN SPECIFICATION, AND THE PENS FUNCTIONED AS INTENDED. AN INJECTION SEQUENCE WAS EXECUTED USING A 29G X 12.7MM BD PEN NEEDLE AND CARTRIDGE. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

Additional Manufacturer Narrative · 0

THE CHANGES ARE AS FOLLOWS: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN AND THE (B)(6) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE BRAND NAME: PEN II MYLAN 3.0ML. MEDICAL DEVICE TYPE: FMI. COMMON DEVICE NAME: PEN. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON. MEDICAL DEVICE CATALOG #: 47314378. MEDICAL DEVICE LOT #: 16218001. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2016-08-18. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: BECTON DICKINSON.

Description of Event or Problem · 0

IT WAS REPORTED THAT NO MEDICATION DELIVERY OCCURRED WITH A PEN II MYLAN 3.0ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONSUMER STATED THAT HE DIALED THE SETTING TO 0.3 AND PUSHED THE INJECTION BUTTON DOWN TO INJECT, BUT NO MEDICATION CAME OUT." 2 OCCURRENCES REPORTED, DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

Description of Event or Problem · 0

IT WAS REPORTED THAT NO MEDICATION DELIVERY OCCURRED WITH A PEN II MYLAN 3.0ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CONSUMER STATED THAT HE DIALED THE SETTING TO 0.3 AND PUSHED THE INJECTION BUTTON DOWN TO INJECT, BUT NO MEDICATION CAME OUT." 2 OCCURRENCES REPORTED, DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT NO MEDICATION DELIVERY OCCURRED WITH A UNSPECIFIED BD¿ PEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CONSUMER STATED THAT HE DIALED THE SETTING TO 0.3 AND PUSHED THE INJECTION BUTTON DOWN TO INJECT, BUT NO MEDICATION CAME OUT." 2 OCCURRENCES REPORTED, DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
444189	PEN II MYLAN 3.0ML	PEN	FMI	BECTON DICKINSON		16218001

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Failure to Deliver

Source type · 2

• OTHER
• USER FACILITY

Type of report · 2

• Followup
• Initial submission