MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE FILL SPKG; INTRAVASCULAR CATHETER

Catalog Number 306553

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that syringe 10ml reg pr saline fill spkg was getting stuck.The following information was provided by the initial reporter: material no: 306553, batch no: unknown (provided 0316028).It was reported syringe is getting stuck in the barrel.Verbatim: the syringe is getting stuck in the barrel not allowing the caregiver to release all the saline.

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Dhr could not be performed due to unknown lot#.

Event Description

It was reported that syringe 10ml reg pr saline fill spkg was getting stuck.The following information was provided by the initial reporter: material no: 306553 batch no: unknown (provided 0316028) it was reported syringe is getting stuck in the barrel.Verbatim: the syringe is getting stuck in the barrel not allowing the caregiver to release all the saline.

• Brand Name: SYRINGE 10ML REG PR SALINE FILL SPKG
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 11369997
• MDR Text Key: 233252122
• Report Number: 9616657-2021-00024
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: 00382903065530
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306553
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1