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

Catalog Number 306553

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 five syringe 10ml reg pr saline fill spkg experienced a breach in sterility.The following information was provided by the initial reporter: material no.306553, batch no.8340710.We have been alerted by our qa department of a quality issue involving an item we source from your company.We are not issuing a supplier corrective action request (scar) at this time but below are the details for your awareness.Vendor item number: 306553; lot number: 8340710; quantity affected: 5; explanation: the packaging of several syringes were found torn as they were taken out of the box which was not damaged.Looks to be damaged from vendor.

Event Description

It was reported that five syringe 10ml reg pr saline fill spkg experienced a breach in sterility.The following information was provided by the initial reporter: material no.306553.Batch no.8340710.We have been alerted by our qa department of a quality issue involving an item we source from your company.We are not issuing a supplier corrective action request (scar) at this time but below are the details for your awareness.Vendor item number: 306553.Lot number: 8340710.Quantity affected: 5.Explanation: the packaging of several syringes were found torn as they were taken out of the box which was not damaged.Looks to be damaged from vendor.

Manufacturer Narrative

Investigation: the returned samples and photos were reviewed and confirm the issue identified.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.It is possible that there may have been a technical issue with the infeed rollover pads during production.Bd has since changed the in feed rollover pads.

• 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: 8600911
• MDR Text Key: 146504302
• Report Number: 9616657-2019-00207
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306553
• Device Lot Number: 8340710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other