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

Catalog Number 306575

Device Problem Break (1069)

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

Event Date 03/18/2022

Event Type  malfunction  

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 bd posiflush¿ pre-filled saline syringe the luer of the syringe broke off.The following information was provided by the initial reporter: "the luer lock connection has broken off in the 3-way valve.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 20-apr-2022.H.6.Investigation: a device history record review was completed for provided material number 306575 and lot number 1336936.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, the affected sample was returned for evaluation by our quality team.The affected sample was received with a pocco line.The tip of the syringe was broken and stuck within the pocco line.As per the sample received, the syringe was connected to the pocco line for flushing and when removing it from the pocco line, the breakage occurred.It can be concluded that the syringe was in good condition prior to use.During production the tip can become damaged if the tip cap is assembled too tightly; however, no issues were identified during the production process related to this defect.It is possible that this defect resulted due to an isolated issue during the production process, although a specific manufacturing related circumstance cannot be determined at this time.H3 other text : see h.10.

Event Description

It was reported bd posiflush¿ pre-filled saline syringe the luer of the syringe broke off.The following information was provided by the initial reporter: "the luer lock connection has broken off in the 3-way valve.".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14056051
• MDR Text Key: 288902306
• Report Number: 3002682307-2022-00108
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/09/2022

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 Catalogue Number: 306575
• Device Lot Number: 1336936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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