MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE FLUSH SYRINGE

Catalog Number 306595

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

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 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: when the nurse used the 10ml specification flush for picc care, it was found that the plunger rod of the product was different from other products when it was pushed forward, and the plunger rod could not be pushed forward when there was 3ml of rinsing fluid left.The nursing operation was completed after replacing the product.

Event Description

It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: when the nurse used the 10ml specification flush for picc care, it was found that the plunger rod of the product was different from other products when it was pushed forward, and the plunger rod could not be pushed forward when there was 3ml of rinsing fluid left.The nursing operation was completed after replacing the product.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 11/24/2020 h.6.Investigation: a device history record review was performed for provided lot number 175464.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 physical sample was received for evaluation by our quality team.It has no tip cap or saline solution.The plunger rod-rubber stopper is at the 4ml mark.A visual inspection was performed and no defects or damages were observed.The sample was then tested for sustaining force and measured within specification, however the result was on the higher end of specification.The cause for this defect could have resulted when the customer noticed that more force than normal was required, even though it is within specification.See h.10.

• Brand Name: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10931697
• MDR Text Key: 219187150
• Report Number: 1911916-2020-01085
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 306595
• Device Lot Number: 0175464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1