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 Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

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.The following information was provided by the initial reporter: "it was reported that syringe leaked out of the plunger.Event description: here is an additional product issue for the prefilled saline syringe, details are below product manufacture number- 8290306546, lot number 0042292 issue identified- syringe leaked out the back of the plunger while infusing into patient's catheter.Date reported 8/27.Xxx xxx has the syringe in her office.Please send a return package for this to be returned for analysis.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 0042292.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported that syringe 10ml reg pr saline 10ml fill leaked.The following information was provided by the initial reporter: "it was reported that syringe leaked out of the plunger.Event description: here is an additional product issue for the prefilled saline syringe, details are below product manufacture number- 8290306546, lot number 0042292 issue identified- syringe leaked out the back of the plunger while infusing into patient's catheter.Date reported 8/27.Xxx xxx has the syringe in her office.Please send a return package for this to be returned for analysis.

• 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: 10557404
• MDR Text Key: 213930810
• Report Number: 1911916-2020-00876
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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 Expiration Date: 01/31/2023
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 0042292
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other