FDA Adverse Event Injury Summary report: N

QUICK SET PARADIGM

MDR report key: 2158747 · Received June 15, 2011

Report

Report Number: 3003442380-2011-20012
Event Type: Injury
Date Received: June 15, 2011
Date of Event: February 22, 2011
Report Date: June 15, 2011
Manufacturer: UNOMEDICAL DEVICES S.A. DE C.V.
Product Code: FPA
PMA / PMN Number: K011071
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS WAS BROUGHT TO UNOMEDICAL A/S ATTENTION ON THE (B)(4) 2011 BY OUR DISTRIBUTOR MINIMED MEDTRONIC. THE INCIDENT WAS REPORTED TO THE FDA UNDER UF/IMPORTER REPORT# (B)(4) ON THE (B)(4) 2011. UNOMEDICAL DID NOT RECEIVE ANY RETURNED DEVICES AND REVIEW OF THE BATCH RECORDS REVEALED NO RELEVANT DEVIATIONS. THE RETAINED SAMPLES WERE TESTED AND FOUND WITHIN PRODUCT SPECIFICATIONS, PLEASE SEE ATTACHED EVAL SUMMARY.

Description of Event or Problem · 1

PT PLACED A QUICKSET CATHETER FOR HER MEDTRONIC INSULIN INFUSION PUMP IN HER LEFT UPPER BUTTOCK. WHEN SHE PULLED THE INTRODUCER NEEDLE BASE/HOLDER OUT, THE NEEDLE WAS NOT PRESENT AND THE HOLDER LOOKED SLIGHTLY JAGGED. BEFORE PLACEMENT, PT REPORTED EVERYTHING LOOKED NORMAL. SHE THEN PULLED THE CATHETER OUT AND THE NEEDLE WAS NOT PRESENT EITHER. PT PLACED ANOTHER CATHETER, PRESENTED FOR X-RAYS THE SAME DAY AND HAD SURGERY TO REMOVE THE NEEDLE UNDER FLUOROSCOPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUICK SET PARADIGM		FPA	UNOMEDICAL DEVICES S.A. DE C.V.	MMT-399	9201296

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR		Other