MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306547

Device Problem Difficult to Advance (2920)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Two potential lot numbers were provided for this incident.The information for each lot number is as follows:  medical device lot #: 7299570, medical device expiration date: 2020-10-31, device manufacture date: 2017-10-26, medical device lot #: 8018974, medical device expiration date: 2021-01-31, device manufacture date: 2018-01-18.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that difficult plunger movement was found with bd posiflush¿ normal saline syringes while pushing to clear the line.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation results: four representative samples were available to bd for evaluation.They all were in the sealed packaging flow wrap, all of them have the plunger rod- rubber stopper, the tip cap, and the saline solution.The barrel labels confirm the lot#8018974.A quality engineer was able to test the plungers for sustaining force.The engineer determined that all of the syringes were under 20n and within specification.Therefore, bd was unable to verify the reported issue.A complaint history check was performed for plunger movement difficult for the reported lots and product.This was the first reported complaint for this issue.This appeared to be an isolated incident and not a system issue.Dhr/bhr review: there were no documented issues for the complaint of batch 7299570 during this production run.There were no documented issues for the complaint of batch 8018974 during this production run.Root cause could not be determined.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7491087
• MDR Text Key: 107619146
• Report Number: 1911916-2018-00179
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 306547
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other