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

Catalog Number 328328

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe pierced through the shield in the polybag and made a small hole in the packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: she informs that when handling the package of the informed batch, she found that one of the syringes had the needle transfixed in the shield.There was an accidental puncture (clean needle), but she mentioned that it was not a serious incident.No medical intervention.I fixed the lid so that no one else gets hurt, but you can see the "small hole" that the needle made in the packaging.

Manufacturer Narrative

H6: investigation summary customer returned several images of a polybag for 1ml, 30 gauge, 8mm syringes from lot 0132312.None of the syringes appear to have a needle sticking through their needle shields in the returned images.The condition of the needles could not be evaluated using the images provided.It has been noted that no previous incidents were reported for this lot.A review of the device history record was completed for batch# 0132312.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, bd was unable to confirm the customer¿s indicated failure of a needle piercing the needle shield.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe pierced through the shield in the polybag and made a small hole in the packaging.The following information was provided by the initial reporter, translated from portuguese to english: "she informs that when handling the package of the informed batch, she found that one of the syringes had the needle transfixed in the shield.There was an accidental puncture (clean needle), but she mentioned that it was not a serious incident.No medical intervention." "i fixed the lid so that no one else gets hurt, but you can see the "small hole" that the needle made in the packaging.".

• Brand Name: BD ULTRA-FINE II INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12230228
• MDR Text Key: 265180343
• Report Number: 1920898-2021-00821
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328328
• Device Lot Number: 0132312
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1