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

Catalog Number 306575

Device Problem Volume Accuracy Problem (1675)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 2 bd posiflush¿ pre-filled saline syringe experienced scale marking missing.The following information was provided by the initial reporter: found x02 syringes of batch no.2271556 without label.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number 306575 and lot number 2271556.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, one (1) picture sample was provided for evaluation by our quality engineer team.Through examination of the picture, two (2) unopened posiflush sp syringes were identified with no barrel label.The picture sample was sufficient in confirming the reported defect.There is a vision system in place during the production process to detect issues with the barrel label, including the defect of missing label.Although no issues were identified during production, this incident most likely resulted after the vision system, due to a failure in the double rejection station.If a syringe has no label, the rejection station must reject it.

Event Description

It was reported that 2 bd posiflush¿ pre-filled saline syringe experienced scale marking missing.The following information was provided by the initial reporter: found x02 syringes of batch no.2271556 without label.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16997026
• MDR Text Key: 315919514
• Report Number: 3002682307-2023-00135
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/01/2023

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: 306575
• Device Lot Number: 2271556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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