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

Catalog Number 329424

Device Problem Delivered as Unsterile Product (1421)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd micro-fine¿ insulin syringe caps were off.This occurred on 3 occasions before use.The following information was provided by the initial reporter: material no: 329424, batch no: unknown (provided 8316939).It was reported picked up the package and needles stuck her causing bleeding.(3 caps were off the sealed bag of syringes).Verbatim: patient was buying a 10 pk of needles.Picked up the package and needles stuck her causing bleeding.(3 caps were off the sealed bag of syringes).(rph) took the patient into the immunization and cleaned her up.Patient is fine.We checked the other bags inside this box and found 2 others that had some lids that come off.Soc notified.

Manufacturer Narrative

Investigation summary: severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle stick (before use/med intervention), harm/bleeding and cannula shield separates on lot # 8316939.Investigation summary: no samples (including photos) 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# 8316939.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that bd micro-fine¿ insulin syringe caps were off.This occurred on 3 occasions before use.The following information was provided by the initial reporter: material no: 329424 batch no: unknown (provided 8316939) it was reported picked up the package and needles stuck her causing bleeding.(3 caps were off the sealed bag of syringes).Verbatim: patient was buying a 10 pk of needles.Picked up the package and needles stuck her causing bleeding.(3 caps were off the sealed bag of syringes)._____(rph) took the patient into the immunization and cleaned her up.Patient is fine.We checked the other bags inside this box and found 2 others that had some lids that come off.-soc notified.

• Brand Name: BD MICRO-FINE INSULIN SYRINGE
• 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: 8931889
• MDR Text Key: 155650818
• Report Number: 1920898-2019-00872
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 329424
• Device Lot Number: 8316939
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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