MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Model Number 328438

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0006864, medical device expiration date: 2025-01-31, device manufacture date: 2020-01-06, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needles experienced the needle going through the shield after recapping and leakage during use.The following information was provided by the initial reporter: material no.328438 batch no.0006864, unknown.Complaint 1 of 2.Consumer reported when removed the needle shields finding the needles to be bent.Replaces the shield to the syringe the needle goes thru shield and sticks his thumb.Advised consumer not to reshield.No medical attention received or will be received for this incident.Consumer reported removes needle shield does not look at the needle completes the injection but finds the needle bent and insulin rolling down stomach.Consumer reported reuses the syringe for his night time injection.He injects 4-5 times a day.Lot #: 0006864 plus other boxes unknown lot #s.Catalog#: 328438.Date of event: unknown.

Event Description

It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needles experienced the needle going through the shield after recapping and leakage during use.The following information was provided by the initial reporter: material no.328438 batch no.0006864, unknown complaint 1 of 2 consumer reported when removed the needle shields finding the needles to be bent.Replaces the shield to the syringe the needle goes thru shield and sticks his thumb.Advised consumer not to reshield.No medical attention received or will be received for this incident.Consumer reported removes needle shield does not look at the needle completes the injection but finds the needle bent and insulin rolling down stomach.Consumer reported reuses the syringe for his night time injection.He injects 4-5 times a day.Lot #: 0006864 plus other boxes unknown lot #s catalog#: 328438 date of event: unknown.

Manufacturer Narrative

H.6.Investigation: customer returned (14) loose 31gx8mm, 0.3ml bd insulin syringes.Consumer reported that needle is bent before injection and when re-shielding the needle goes through the shield and sticks his finger; also, reported insulin is rolling down stomach after injection.All 14 returned syringes were examined, and the following was observed: 1 syringe with a bent cannula through shield 11 syringes with bent cannula 2 syringes with straight cannula no evidence of manufacturing defect was observed.All 14 syringes were tested for flow: all 14 syringes were able to draw and expel properly.Since all 14 syringes were returned after use, and no manufacturing defects were observed, the probable cause of the bent cannulas and cannula through shield is user error: if the user removes or reattaches the cannula shield obliquely they may bend the cannula and potentially cause the cannula to pierce the shield.A review of the device history record was completed for batch # 0006864 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.- confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (cannula bent, cannula through shield) - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (leakage) h3 other text : see h.10.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10479499
• MDR Text Key: 206359754
• Report Number: 1920898-2020-01147
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 328438
• Device Catalogue Number: 328438
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other