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

Model Number 306546

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported while using bd posiflush¿ normal saline syringes there was a crack in the device and the saline leaked.There was no report of patient impact.The following information was provided by the initial reporter: normal saline (ns) dispelled out of syringe via crack visible on the side of the device.

Manufacturer Narrative

Date of event is unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was completed for provided material number (b)(4)and lot number 2019369.Although all final inspections performed were found to be acceptable, a second sample for leakage due to a damaged syringe was performed.The damaged syringe that resulted in the second sampling occurred within the fill machine, due to a jam.While this second sample could be related to the reported issue, as samples were not available for return, the defect could not be confirmed.This is a very unusual circumstance.The barrel component is inspected at the molding area and the fill room.The barrel is again inspected at the packaging step for the presence of the barrel label.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.Further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported while using bd posiflush¿ normal saline syringes there was a crack in the device and the saline leaked.There was no report of patient impact.The following information was provided by the initial reporter: normal saline (ns) dispelled out of syringe via crack visible on the side of the device.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGES
• 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: 14466298
• MDR Text Key: 292601288
• Report Number: 1911916-2022-00269
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• 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
• Report Date: 08/01/2022

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 Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 2019369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/21/2022
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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