MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 328521

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Foreign Body In Patient (2687)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during injection the needle broke off in arm, which was removed with a relion® insulin syringe.The following information was provided by the initial reporter: (1 of 2 complaints).It was reported that needle broke off in arm during injection.Needle was removed by husband.Bled after needle was removed.

Event Description

It was reported that during injection the needle broke off in arm, which was removed with a relion® insulin syringe.The following information was provided by the initial reporter: (1 of 2 complaints).It was reported that needle broke off in arm during injection.Needle was removed by husband.Bled after needle was removed.

Manufacturer Narrative

Investigation: customer returned (1) loose 3/10cc, 6mm, 31g relion syringe in an open poly bag from lot # 9105545.Customer states that the needle broke off in the arm, she felt a little burn, there was bleeding, it bends easily.The returned syringe was examined and exhibited a bent cannula.No broken cannula was observed.A review of the device history record was completed for batch #9105545.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one notification [200818977] noted that did not pertain to the complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent cannula).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (broken cannula).After visual inspection of the sample, we would confirm that it is bent cannula and happened after getting cannulated, passed the pim inspection for cannula angularity.It must have happened during the process of shielding.

Manufacturer Narrative

The following fields have been updated with additional information: d.4.Medical device lot #: 9105545, d.4.Medical device expiration date: n/a, h.4.Device manufacture date: 2019-06-06 h3 other text : see h.10.

Event Description

It was reported that during injection the needle broke off in arm, which was removed with a relion® insulin syringe.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported that needle broke off in arm during injection.Needle was removed by husband.Bled after needle was removed.

• Brand Name: RELION INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9129166
• MDR Text Key: 189871299
• Report Number: 1920898-2019-01046
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138383
• UDI-Public: 00681131138383
• 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,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328521
• Device Lot Number: 9105545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other