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

Catalog Number 306546

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ normal saline syringe would not flush completely.This is 4 of 4 related events.The following information was provided by the initial reporter: i had a nurse give me a saline flush syringe that would not flush.Several staff tried, including myself.She reported that it happened last week and she thought nothing of it, just a fluke.Then it happened again on monday.I do have the syringe.At first glance it looks okay.She was able to flush about 7 cc (noted with some difficulty) but then towards the end, it wouldn't flush at all.Staff even thought the iv was bad because it wouldn't flush.It looks like the plunger is "defective" kind of bent keeping it from going forward anymore.I did push and pull and eventually was able to then move the plunger.Sharing in case others have reported this issue with the 10 ml bd prefilled saline syringe.Cs responded on (b)(6) lot 2326216 on each syringe given to me the nurse thought the iv was bad, restarted it.No other harm.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 2326216.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported that the bd posiflush¿ normal saline syringe would not flush completely.This is 4 of 4 related events.The following information was provided by the initial reporter: i had a nurse give me a saline flush syringe that would not flush.Several staff tried, including myself.She reported that it happened last week and she thought nothing of it, just a fluke.Then it happened again on monday.I do have the syringe.At first glance it looks okay.She was able to flush about 7 cc (noted with some difficulty) but then towards the end, it wouldn't flush at all.Staff even thought the iv was bad because it wouldn't flush.It looks like the plunger is "defective" kind of bent keeping it from going forward anymore.I did push and pull and eventually was able to then move the plunger.Sharing in case others have reported this issue with the 10 ml bd prefilled saline syringe.Cs responded on 3/31 march 24, march 27, march 29.Lot 2326216 on each syringe given to me the nurse thought the iv was bad, restarted it.No other harm.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-may-2023.It was reported the syringe would not flush.To aid in the investigation, two empty samples with no packaging flow wrap or tip cap were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.A device history record review was completed for provided material number 306546, lot 2326216.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.H3 other text : see h10.

Event Description

It was reported that the bd posiflush¿ normal saline syringe would not flush completely.This is 4 of 4 related events.The following information was provided by the initial reporter: i had a nurse give me a saline flush syringe that would not flush.Several staff tried, including myself.She reported that it happened last week and she thought nothing of it, just a fluke.Then it happened again on monday.I do have the syringe.At first glance it looks okay.She was able to flush about 7 cc (noted with some difficulty) but then towards the end, it wouldn't flush at all.Staff even thought the iv was bad because it wouldn't flush.It looks like the plunger is "defective" kind of bent keeping it from going forward anymore.I did push and pull and eventually was able to then move the plunger.Sharing in case others have reported this issue with the 10 ml bd prefilled saline syringe.Cs responded on 3/31.March 24, march 27, march 29.Lot 2326216 on each syringe given to me.The nurse thought the iv was bad, restarted it.No other harm.

• 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
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16757096
• MDR Text Key: 313944363
• Report Number: 1911916-2023-00240
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 2326216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1