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

Catalog Number 306574

Device Problem Defective Component (2292)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ pre-filled saline syringe experienced a broken tube.The following information was provided by the initial reporter, translated from japanese to english: broken tube.

Manufacturer Narrative

Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary : a device history record review was completed for provided material number 306574 and lot number 2152611.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, picture samples were provided for evaluation by our quality engineer team.Through examination of the pictures, several syringes were observed with broken unit packaging film near the plunger area and one syringe was observed broken.The defective packaging film resulted from the spikes that perforate the film.If the perforation is not well adjusted, the perforation becomes too large which can lead to tearing when the syringes are picked up and placed within the shelf cartons.A previous project was opened to further investigate the spikes and the broken packaging film.All of the spike positions have been checked and corrected.The damaged syringe most likely resulted due to a jam during the barrel feeding and plunger assembly process.If a jam occurs, the operator must ensure that no damaged syringes are packaged.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.

Event Description

It was reported that the bd posiflush¿ pre-filled saline syringe experienced a broken tube.The following information was provided by the initial reporter, translated from japanese to english: broken tube.

• 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: 16117470
• MDR Text Key: 308633367
• Report Number: 3002682307-2022-00364
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 01/10/2023

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: 306574
• Device Lot Number: 2152611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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