MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.3ML, 31G X 8MM BD RELION® INSULIN SYRINGE

Catalog Number 328512

Device Problem Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/03/2017

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.(b)(4).

Event Description

It was reported that a consumer had difficulty removing the cap of a 0.3ml, 31g x 8mm bd relion® insulin syringe and suffered a needle stink injury before use.The consumer stated that this occurred three separate times.There was no report of medical intervention.

Manufacturer Narrative

Results: a sample has not yet been received for evaluation.However, the manufacturing site has conducted a device history record review.The review revealed no irregularities during the manufacture of the reported lot # 6291669.Conclusion: a conclusion is not yet available as the evaluation is still in progress.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Four syringes in an open poly bag were returned for evaluation.All returned syringes were tested to determine the shield removal forces and all removal forces fall within specifications.However, one sample exhibited a bent cannula.The sample with bent needle was further viewed under 4x magnification and showed potential signs of having been manually adjusted for angularity, proximal to the adhesive/cannula/hub contact point.It is unclear as to whether the cannula had been tampered or altered prior to receipt.As previously reported, a review of the device history record revealed no irregularities during the manufacture of the reported lot # 6291669.Conclusion: although one of the returned syringes exhibited a bent cannula, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 0.3ML, 31G X 8MM BD RELION® INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6523446
• MDR Text Key: 73910924
• Report Number: 1920898-2017-00053
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328512
• Device Lot Number: 6291669
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other