FDA Adverse Event Malfunction Summary report: N

18 G X 1.5 IN. BD PRECISIONGLIDE¿ NEEDLE

MDR report key: 6746100 · Received July 26, 2017

Report

Report Number: 1911916-2017-00094
Event Type: Malfunction
Date Received: July 26, 2017
Date of Event: May 18, 2017
Report Date: July 26, 2017
Manufacturer: BD MEDICAL (BD WEST) MEDICAL SURGICAL
Product Code: FMI
PMA / PMN Number: K021475
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 05/19/2017 VIA MEDWATCH # MW5069963. ONE SAMPLE WAS RETURNED. THERE WAS AN EPOXY DRIPOVER ON THE SIDE OF THE HUB. NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. DHR REVIEW: ASSEMBLY BATCH 6153615 HAD 101 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. ASSEMBLY BATCH 6153617 HAD 107 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. AN EPOXY DRIPOVER GENERALLY OCCURS WHEN THE EPOXY APPLICATOR FAILS TO SHUT OFF FOR A MISSING CANNULA. WE WILL CONTINUE TO PROVIDE COACHING AND FEEDBACK TO THE OPERATORS AS WE BECOME AWARE OF ISSUES. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A WHITE SUBSTANCE WAS FOUND ALONG THE HUB OF AN 18 G X 1.5 IN. BD PRECISIONGLIDE¿ NEEDLE. NO INJURY OR MEDICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
523877	18 G X 1.5 IN. BD PRECISIONGLIDE¿ NEEDLE	SAFETY ENGINEERED NEEDLE	FMI	BD MEDICAL (BD WEST) MEDICAL SURGICAL		6152775

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other