MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; FLUSH-SALINE

Catalog Number 306546

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 10 ml bd posiflush¿ normal saline syringe had an occurrence where the plunger rod does not go all they way down.

Event Description

It was reported 10 ml bd posiflush¿ normal saline syringe had an occurrence where the plunger rod does not go all they way down.

Manufacturer Narrative

H.6.Investigation summary: the non-conformances were reviewed for this batch and there was a record of non-conformance associated with this batch for this defect.The samples received as part of this complaint confirms plunger movement difficulty.There was an intermittent issue with the silicon hosing which was investigated and resolved at that time.All product associated with the defect was held for inspection, and any affected material was scrapped.Although, it is possible that the product related to this complaint may have been manufactured prior to detection or there may have been a limited occurrence of product which was produced outside the contained material.Conclusion(s): the hosing at the silicon station in fill room was investigated and issue resolved.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH-SALINE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8414160
• MDR Text Key: 140948305
• Report Number: 9616657-2019-00141
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7110587
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other