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

Catalog Number 306595

Device Problem Leak/Splash (1354)

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

Event Date 11/24/2021

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.

Event Description

It was reported that the bd posiflush¿ normal saline syringe barrel was broken and leaked fluid during the injection.This occurred with 14 separate syringes.The following information was provided by the initial reporter, translated from (b)(6): "during use, it was found that the flush was broken, and the fluid flowed out during the injection".

Event Description

It was reported that the bd posiflush¿ normal saline syringe barrel was broken and leaked fluid during the injection.This occurred with 14 separate syringes.The following information was provided by the initial reporter, translated from chinese: "during use, it was found that the flush was broken, and the fluid flowed out during the injection".

Manufacturer Narrative

H6: investigation: it was reported the flush is broken.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe with no packaging flow wrap or tip cap.The syringe barrel has a crack.No other defects or imperfections were observed.This defect could occur if there was a jam during the plunger rod assembly process inducing the crack to the barrel.A device history record review was completed for provided material number 306595, lot number 1152464.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the plunger rod assembly station was performed.The settings were correct and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13057033
• MDR Text Key: 286350877
• Report Number: 1911916-2021-01283
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306595
• Device Lot Number: 1152464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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