MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR; PISTON SYRINGE

Catalog Number 328322

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 a syringe 0.3ml 30ga 8mm 10bag 500 l amr had the needle cannula through the needle shield in the polybag before use.The following was reported by the initial reporter: "pharmaceutical manager contacted us informing a quality deviation in the bd ultra-fine 8mm needles capacity 30ui, informed that they acquired the syringes from the distributor and when the attendant was launching the product in the system, it was punctured with the needle of the syringe that was crossed in the cover protective.In the form sent it is informed that there was an accidental prick with the needle, but there was no medical or surgical intervention, only performed asepsis at the puncture site.".

Event Description

It was reported that a syringe 0.3ml 30ga 8mm 10bag 500 l amr had the needle cannula through the needle shield in the polybag before use.The following was reported by the initial reporter: "pharmaceutical manager contacted us informing a quality deviation in the bd ultra-fine 8mm needles capacity 30ui, informed that they acquired the syringes from the distributor and when the attendant was launching the product in the system, it was punctured with the needle of the syringe that was crossed in the cover protective.In the form sent it is informed that there was an accidental prick with the needle, but there was no medical or surgical intervention, only performed asepsis at the puncture site.".

Manufacturer Narrative

H6: investigation summary: customer returned two images of a pouch labeled for 0.3ml, 30 gauge, 8mm syringes from lot 9077904.The pouch does not appear to have been opened.Inside the pouch is a syringe with the needle sticking out the side of the needle shield at an angle.A review of the device history record was completed for batch # 9077904 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause cannot be determined.Based on the images received, bd was able to confirm the customer¿s indicated failure of the needle shield being pierced by the needle cannula, potentially resulting in a needle stick.H3 other text : see h10.

• Brand Name: SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11429604
• MDR Text Key: 246822198
• Report Number: 1920898-2021-00277
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 328322
• Device Lot Number: 9077904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1