MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL BNS; PISTON SYRINGE

Catalog Number 309648

Device Problem Packaging Problem (3007)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is (b)(6).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 syringe 1ml ll bns was damaged.The following information was provided by the initial reporter: material no:309648, batch no: 1035281.It was reported that the item is not sterile and damaged.

Manufacturer Narrative

This complaint is not mdr reportable.Damaged bulk packaging does not affect the integrity or sterility of the device, since it is shipped non-sterile.This may lead to customer dissatisfaction but will not lead to harm or serious injury.The initial mdr is void.

Event Description

It was reported that syringe 1ml ll bns was damaged.The following information was provided by the initial reporter: material no:309648 batch no: 1035281.It was reported that the item is not sterile and damaged.

• Brand Name: SYRINGE 1ML LL BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11766778
• MDR Text Key: 267452789
• Report Number: 1213809-2021-00285
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309648
• Device Lot Number: 1035281
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1