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

Catalog Number 306547

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown, medical device lot #: 9113773, medical device expiration date: 2022-04-30, device manufacture date: 2019-04-23.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: we found some of the smartsite samples that we were using for some antimicrobial efficacy testing with caps were difficult to flush (i.E, when the luer lock flush syringes were connected to them, there was significant resistance as if the valves didn¿t open).The operator had to try 2-3 times to get them to work.

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: we found some of the smartsite samples that we were using for some antimicrobial efficacy testing with caps were difficult to flush (i.E, when the luer lock flush syringes were connected to them, there was significant resistance as if the valves didn¿t open).The operator had to try 2-3 times to get them to work.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided material number 306547 and lot number 9113773.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one video was received for evaluation by our quality team.The video shows a smartsite device with a syringe.The device is under lab testing and shows performance issues.The actual sample would be needed to confirm the symptom reported by the customer.Based on the investigation with no sample analysis the symptom reported by the customer could not be confirmed and a cause for the reported incident could not be determined.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: 10952276
• MDR Text Key: 221011860
• Report Number: 1911916-2020-01100
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306547
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1