MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH PREFILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Break (1069)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

It was reported that bd posiflush prefilled syringe tip broke.The following information was provided by the initial reporter, translated from korean to english: the tips of the syringes were broken while the user was connecting to the posiflush 10cc and the 3-way stopcock.

Manufacturer Narrative

A device history record review was completed for provided material number 306575 and lot number 3110847.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, two (2) syringe sample were received for evaluation by our quality team.The syringes arrived without the tip components and a used 3-way stopcock product.The tips were stuck within the 3-way stopcock, confirming the reported defect.An exact cause related to the manufacturing process could not be determined for this incident.The samples showed a clean break at the syringe tip.This type of breakage is not produced during the manufacturing process.Per the provided feedback, the syringes were used without issue prior to breakage upon disconnection.We strongly recommend that the instructions for use are followed when connecting and disconnecting the bd posiflush syringe, taking into account that it is designed to be used with iso luer compliant components for intravenous applications.Once used, disconnect the syringe by unscrewing completely; never pull or bend the tip as it may result in breakage.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD POSIFLUSH PREFILLED 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18295277
• MDR Text Key: 330142893
• Report Number: 3002682307-2023-00353
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306575
• Device Lot Number: 3110847
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1