FDA Adverse Event Malfunction Summary report: N

UNSPECIFIED BD PEN NEEDLE

MDR report key: 8663370 · Received June 3, 2019

Report

Report Number: 2243072-2019-01077
Event Type: Malfunction
Date Received: June 3, 2019
Date of Event: May 17, 2019
Report Date: May 17, 2019
Manufacturer: BECTON DICKINSON
Product Code: FMI
PMA / PMN Number: UNKNOWN
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: ONE OPENED PEN NEEDLE SAMPLE WAS RETURNED FROM AN UNKNOWN LOT. NO., CAT. NO. UNKNOWN. A CLOG TEST WAS CARRIED OUT AND NO ISSUES WERE OBSERVED. INVESTIGATION CONCLUSION: NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. ROOT CAUSE DESCRIPTION: NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE NEEDLE WAS UNABLE TO DELIVER MEDICATION WITH AN UNSPECIFIED BD PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BLOCKED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
455001	UNSPECIFIED BD PEN NEEDLE	PEN NEEDLE	FMI	BECTON DICKINSON		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other