MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Mechanical Jam (2983)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ pre-filled saline syringe experienced plunger movement difficult.This is 2 of 2 related events.The following information was provided by the initial reporter: defomed syringes.Slightly narrow and crooked.Pre-filled 10-ml nacl (saline) syringe cannot be used to inject the entire amount of nacl (saline).When nurses stand with patients and have to flush nacl (saline) intravenously, it stops and they perceive it as the needle has stopped working.The problem has occurred a number of times in early february and now the problem is repeating itself again.It's like single syringes are a little crooked or narrower pretty accurate at 3ml.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd posiflush¿ pre-filled saline syringe experienced plunger movement difficult.This is 2 of 2 related events.The following information was provided by the initial reporter: defomed syringes.Slightly narrow and crooked.Pre-filled 10-ml nacl (saline) syringe cannot be used to inject the entire amount of nacl (saline).When nurses stand with patients and have to flush nacl (saline) intravenously, it stops and they perceive it as the needle has stopped working.The problem has occurred a number of times in early february and now the problem is repeating itself again.It's like single syringes are a little crooked or narrower pretty accurate at 3ml.

Manufacturer Narrative

H6: investigation summary as samples were unavailable for return, ten (10) retained samples of the same lot number were obtained from the manufacturing facility.A silicone distribution test was performed on the retained samples.The test results showed three (3) syringes with less silicone at the end of the barrel, another three (3) with homogenous but lighter distribution, and the remaining syringes were totally siliconized with a higher quantity.The results were not able to confirm plunger movement difficulties as there was silicone distribution within each sample.A device history record review was completed for provided material number 306575 and lot number 2263053.The review did not reveal any quality notifications during the production process; however, two second samples were performed that were found to be acceptable and corrective maintenance was carried out.It is possible that the defective samples were produced at some point between the second samplings identified.The possibility of molding defect can be discarded as the barrel diameter would be affected as a whole, not a portion, due to the molding process.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16916025
• MDR Text Key: 315099884
• Report Number: 3002682307-2023-00112
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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 Catalogue Number: 306575
• Device Lot Number: 2263053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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