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

Catalog Number 306595

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

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 the bd posiflush¿ normal saline syringe had no tip cap.The following information was provided by the initial reporter, translated from (b)(6) to english: "when tearing open the package and found that the product has no white cone cap.".

Event Description

It was reported that the bd posiflush¿ normal saline syringe had no tip cap.The following information was provided by the initial reporter, translated from chinese to english: "when tearing open the package and found that the product has no white cone cap.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-11-02.H6: investigation summary a device history record review was performed for provided lot number 94101.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, one sample was received for evaluation by our quality team.The sample came with an opened packaging blister and has no tip cap.The sensor at the production line was challenged with the sample received, to which the sensor detected and rejected it.There are sensors at the fill machine, at the assembly and packaging to detect a missing tip cap.A cause for this defect could not be offered at this time.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

• Brand Name: BD POSIFLUSH NORMAL SALINE SYRINGE
• 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: 10817306
• MDR Text Key: 230279763
• Report Number: 1911916-2020-01019
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 306595
• Device Lot Number: 0094101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1