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

Model Number 306553

Device Problem Packaging Problem (3007)

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

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 10ml reg pr saline fill spkg package was contaminated on 8 occasions before use.The following information was provided by the initial reporter: it was reported that contamination was discovered on the packages of 8 syringes.

Manufacturer Narrative

Investigation summary: a device history record review was performed for provided lot number 0044535 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer.Through examination of the samples, foreign matter was observed on the packaging of the syringe.The physical samples were evaluated and the foreign matter did not appear to affect the product package seal.It has been determined that the foreign matter was a result of a waste trim removal pipe in the multivac packaging machine.An adjustment was made to the trim removal pipe element of the multivac machine to allow a smoother run of operation and prevent this issue from recurring.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.

Event Description

It was reported that syringe 10ml reg pr saline fill spkg package was contaminated on 8 occasions before use.The following information was provided by the initial reporter: it was reported that contamination was discovered on the packages of 8 syringes.

• 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: 10047975
• MDR Text Key: 195957607
• Report Number: 9616657-2020-00074
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 0044535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other