MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE VASCULAR ACCESS FLUSH

Model Number 306547

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The reported lot #: 0148582 was not found for the reported catalog #: 306547.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the syr 10ml pump compatible saline 10ml fil plunger rod would not move forward during the flush.The following information was provided by the initial reporter: "plunger rod did not move forward when trying to flush line".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.: device available for eval yes, d.10.: returned to manufacturer on: 2020-11-08.H.6.Investigation: a device history record review was completed for provided material number 306547 and lot number 0148582.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, two physical samples were received for evaluation by our quality team.They came with no tip cap or saline solution.A visual inspection was performed and no damages or defects were observed.The samples were then tested for sustaining force and all results were found to be within specification.Based on the investigation results, the sample received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.

Event Description

It was reported that the syr 10ml pump compatible saline 10ml fil plunger rod would not move forward during the flush.The following information was provided by the initial reporter: "plunger rod did not move forward when trying to flush line.".

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• 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: 10889366
• MDR Text Key: 225599243
• Report Number: 1911916-2020-01049
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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 Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1