MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5ML 31G X 6MM U-500 INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	326730
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of 0.5ml 31g x 6mm u-500 insulin syringe experienced the needle piercing through the cap/shield.The following information was provided by the initial reporter: material no.: 326730, batch no.: unknown.It was reported that when recapping the needle, it is easy to redirect the needle tip to pierce the outer cap leading to a needle stick.Verbatim: when drawing up and recapping u-500 insulin syringes, it is quite easy to redirect the needle tip to pierce the outer cap leading to a needle stick.
Additional Manufacturer Narrative
Investigation: customer returned a photo of a u500 insulin syringe.Customer states that when drawing up and recapping u-500 insulin syringes, it is quite easy to redirect the needle tip to pierce the outer cap leading to a needle stick.The attached photo was examined and exhibited the cannula through the shield, exposing the cannula, which could lead to a needle stick.Unable to perform dhr check for cannula through shield (reshield) and needle stick (after use) due to unknown lot number.Bd was able to duplicate or confirm the customer¿s indicated failure.As per customer, this issue occurred when reshielding the syringe.
Event or Problem Description
It was reported that an unspecified number of 0.5ml 31g x 6mm u-500 insulin syringe experienced the needle piercing through the cap/shield.The following information was provided by the initial reporter: material no.: 326730 batch no.: unknown.It was reported that when recapping the needle, it is easy to redirect the needle tip to pierce the outer cap leading to a needle stick.Verbatim: when drawing up and recapping u-500 insulin syringes, it is quite easy to redirect the needle tip to pierce the outer cap leading to a needle stick.

• Brand Name: 0.5ML 31G X 6MM U-500 INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8514302
• Report Number: 1920898-2019-00348
• Device Sequence Number: 19501981
• Product Code: FMF
• UDI-Device Identifier: 00382903267309
• UDI-Public: 00382903267309
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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
• Operator of Device: Other
• Device Catalogue Number: 326730
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other