MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS; PISTON SYRINGE

Catalog Number 304050

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 barrel 1cc s/t w/sil no bd logo/tb bns leaked blood at the needle connection while drawing an abg.The following information was provided by the initial reporter: "when drawing an abg the syringe plugger will not aspirate the sample correctly, and the blood sample leaks out at the needle connection.".

Event Description

It was reported that the barrel 1cc s/t w/sil no bd logo/tb bns leaked blood at the needle connection while drawing an abg.The following information was provided by the initial reporter: "when drawing an abg the syringe plugger will not aspirate the sample correctly, and the blood sample leaks out at the needle connection.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the reported condition were received the reported defect could not be confirmed.A device history record review was completed for provided lot number 0233244.A review showed insufficient silicone issue was reported during the production.Product was requalified per applicable acceptable quality limit before production resumed.

• Brand Name: BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12520451
• MDR Text Key: 272954043
• Report Number: 1213809-2021-00651
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304050
• Device Lot Number: 0233244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1