MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML REG PR SALINE 10ML FILL; PREFILLED SALINE SYRINGE

Catalog Number 30654678

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0114381, medical device expiration date: 2023-04-30, device manufacture date: 2020-04-23, medical device lot #: 0021634, medical device expiration date: 2023-01-31, device manufacture date: 2020-01-21.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 3 syringe 10ml reg pr saline 10ml fill experienced difficult plunger movement during use.The following information was provided by the initial reporter: i have received the following product complaint for item number 30654678: 9 sodium chloride flushes, not flushing several sodium chloride flushes not flushing properly.Syringe does not move forward when you push on it and therefore you are not able to flush.This was not an isolated incident, this report is just one example lot numbers found with defective flushes so far: lot #0114381 (x2 flushes).Lot #0021634.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot numbers 0114381 and 0021634.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 3 syringe 10ml reg pr saline 10ml fill experienced difficult plunger movement during use.The following information was provided by the initial reporter: i have received the following product complaint for item number (b)(4): 9 sodium chloride flushes - not flushing several sodium chloride flushes not flushing properly.Syringe does not move forward when you push on it and therefore you are not able to flush.This was not an isolated incident, this report is just one example lot numbers found with defective flushes so far: lot #0114381 (x2 flushes) lot #0021634.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10625570
• MDR Text Key: 213232717
• Report Number: 1911916-2020-00926
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• 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: 10/05/2020

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 Catalogue Number: 30654678
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other