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

Model Number 324910

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 06/29/2020

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 #: 0034852, medical device expiration date: 2025-02-28, device manufacture date: 2020-02-03, medical device lot #: 9308367, medical device expiration date: 2024-11-30, device manufacture date: 2019-11-04.(b)(4).Investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 0034852.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 9308367.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification (b)(4) noted that did not pertain to the complaint.Occurrence: a complaint history check was performed and this is the 1st related complaint for needle separates (stuck in skin), needle dull, needle pain on lot(s) # 0034852 and 9308367.A review of risk management (b)(4) indicates that the potential risk of this specific reported incident (syringe, needle separates (stuck in skin), needle dull, needle pain) was captured and addressed appropriately.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd insulin syringe with the bd ultra-fine¿ needle broke off during use and got stuck in the consumer's skin, which was pulled out by the consumer.Lot#'s 0034852 and 9308367 were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: "consumer reported when she pushes the plunger rod in to give herself her injections, the needle gets stuck in her skin and she has to pull it out.Stated the needle tips also appear to not be sharp and it is causing painful injections.Stated she did not want to use anymore of these syringes and notified her pharmacist.".

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• 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: 10248733
• MDR Text Key: 198926352
• Report Number: 1920898-2020-00820
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 324910
• Device Catalogue Number: 324910
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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