MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 8MM; PISTON SYRINGE

Model Number 928858

Device Problem Leak/Splash (1354)

Patient Problems Bruise/Contusion (1754); Pain (1994); Pressure Sores (2326)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9203895.Medical device expiration date: 2024-07-31.Device manufacture date: 2019-07-22.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown." a sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the needle hub separated from device during use with a bd syringe 0.3ml 31ga 8mm.The following information was provided by the initial reporter: it was reported that the consumer stated the needle hub separated when removing the shield.

Manufacturer Narrative

H.6.Investigation: customer returned two (2) loose 0.3ml insulin syringes.Consumer reported the needle hub separated when removing the shield, stated finding syringes with the needle missing altogether, the needles are bent when removing the shield, and the shields are hard to remove; also, when taking the injection, it feels like the needle is not sharp and some bruising and pain occurs.Both returned syringes were examined, and it was observed that both syringes exhibited a needle hub/shield assembly separated from the syringe barrel; no damage to the barrel tips was observed, and only one separated needle hub/shield assembly was returned.A review of the device history record was completed for batch# 9203895.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200837337, 200837237] noted that did not pertain to the complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (needle missing, needle dull) process summary: automatic syringe assembly machine, which feeds 3/10cc, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Dhr, l2l dispatches, and logbook entries were looked at, nothing pertaining to this defect was found.Root cause for this defect cannot be determined.Capa#1630423 was initiated.

Event Description

It was reported that the needle hub separated from device during use with a bd syringe 0.3ml 31ga 8mm.The following information was provided by the initial reporter: it was reported that the consumer stated the needle hub separated when removing the shield.

• Brand Name: BD SYRINGE 0.3ML 31GA 8MM
• Type of Device: PISTON 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 ; 8015652341
• MDR Report Key: 10505695
• MDR Text Key: 207155309
• Report Number: 1920898-2020-01176
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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