MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE¿ INSULIN PEN NEEDLE

Catalog Number 320122

Device Problems Fluid/Blood Leak (1250); Application Program Problem: Medication Error (3198)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that several bd ultra fine¿ insulin pen needle(s) leaked during use, resulting in incorrect dosage and elevated blood sugar for the consumer.There was no report of serious injury or medical interventions.

Manufacturer Narrative

Investigation results: severity: s2; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defects/conditions on lot number 7256602.Customer returned ( 7 ) sealed 4mm, 32g bd pen needles.Consumer states the needles are leaking resulting in elevated blood sugar.All returned pen needles were tested for flow as well as for point geometry, outer diameter and lube coverage.The following was observe: data: point (pe/npe) outer diameter (in) lube sample 1: good/good, 0.0091, good.Sample 2: good/good, 0.0092, good.Sample 3: good/good, 0.0092, good.Sample 4: good/good, 0.0091, good.Sample 5: good/good, 0.0091, good.Sample 6: good/good, 0.0090, good.Sample 7: good/good, 0.0092, good.Leakeage was not observed on any of the returned and tested samples; the alleged deffect could not be confirmed.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the investigation, no additional investigation and no capa is required at this time.

• Brand Name: BD ULTRA FINE¿ INSULIN PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 7397709
• MDR Text Key: 104537083
• Report Number: 9616656-2018-00079
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: 10885403928659
• Combination Product (y/n): N
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320122
• Device Lot Number: 7256602
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other