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

Catalog Number 306595

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

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 plunger in the bd posiflush¿ normal saline syringe was difficult to move.This occurred 10 times during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "2020.9.1, picc clinic, during catheter maintenance, a bolus injection of 10ml flush and the remaining 3ml cannot be continued.The bolus injection can only be carried out in drops.In addition, the customer feedback before the recent use of open security.The "click" sound is not felt in the device, which is different from the previous experience.".

Event Description

It was reported that the plunger in the bd posiflush¿ normal saline syringe was difficult to move.This occurred 10 times during use.The following information was provided by the initial reporter, translated from chinese to english: "(b)(6) 2020, picc clinic, during catheter maintenance, a bolus injection of 10ml flush and the remaining 3ml cannot be continued.The bolus injection can only be carried out in drops.In addition, the customer feedback before the recent use of open security.The "click" sound is not felt in the device, which is different from the previous experience.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/24/2020.H.6.Investigation: a device history record review was performed for provided lot number 0014503.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, 2 physical samples were received for evaluation by our quality team.Through examination of the samples, a visual inspection was performed and no defects were observed.A force test was completed and both samples were within specification.The complaint could not be confirmed and the root cause is undetermined.

• 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: 10570999
• MDR Text Key: 208647086
• Report Number: 1911916-2020-00891
• 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: 09/25/2020

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 306595
• Device Lot Number: 0014503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other