MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2020

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.(b)(4).

Event Description

It was reported that syringe 10ml reg pr saline 10ml fill leaked on 5 occasions before use.The following information was provided by the initial reporter: complaint from private laboratory.The user complained that the syringes were sunken.Saline cannot be injected properly and leakage was caused as well.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-22 h6: investigation summary a device history record review was performed for provided lot number 9168721.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 incident, 2 picture samples and 5 physical samples were received for evaluation by our quality team.Visual inspection of the 5 samples were preformed and all syringes have a deformation in the barrel at 1" from the barrel flange.No other defects were observed.The two pictures provided show the sample received.The cause for this defect could have resulted during the manufacturing process where the divider mechanism had a jam that induced the damage.The process was reviewed and setting of the machine found the machinery was found to be good.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that syringe 10ml reg pr saline 10ml fill leaked on 5 occasions before use.The following information was provided by the initial reporter: complaint from private laboratory.The user complained that the syringes were sunken.Saline cannot be injected properly and leakage was caused as well.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10705994
• MDR Text Key: 213928356
• Report Number: 1911916-2020-00964
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 9168721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other