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

Catalog Number INCORRECT ENTRY

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/08/2023

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.B3.The date received by manufacturer has been used for this field.Numerous lot numbers provided, but the customer was not able to verify which if any were affected: "therefore, the lot is not known and cannot be evaluated.The following lots were delivered to the healthcare facility in the period from the end of august to the end of november 2023".Delivery / lot: 22.11.23: 32702 02.11.23: 3241284 16.10.23: 3249900 02.10.23: 3228924 14.09.23: 3199120 25.08.23: 3193790.

Event Description

It was reported that bd posiflush is missing labeling in its barrel.The following information was provided by the initial reporter, translated from german to english: unlabeled prefilled syringe.No label.Prefilled syringe is not labeled (no label).Contents not known.The syringe was not removed from the original packaging (carton).When did the incident occur? before use.

Manufacturer Narrative

A device history record review was completed for provided material number 306575 and potential lot numbers 3193790, 3199120, 3228924, 3249900, 3241284, 3270281.The review did not reveal any detected abnormalities during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one (1) picture sample and the affected physical sample were returned for evaluation by our quality team.Through examination of the samples, the syringe was observed in a sealed unit package with the barrel label missing.An additional two (2) shelf cartons of retained samples for each of the potential lot numbers were obtained from the manufacturing facility.The retained samples were examined and no defects were identified.Although an exact cause was not identified during the production process, it is most likely that the missing barrel label resulted from an error in the double rejection station.There is a vision system in place to detect missing labels.If there is no label, the rejection station must reject the syringe; however, if there is a failure in the rejection, the machine stops and the operator must resolve the issue.It is possible that an error occurred with this process or that the detection sensor was not detecting properly.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.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.

Event Description

No additional information.

• Brand Name: BD POSIFLUSH
• 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) ; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520 ; 8015652341
• MDR Report Key: 18434781
• MDR Text Key: 331788701
• Report Number: 3002682307-2023-00366
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: INCORRECT ENTRY
• Device Lot Number: INCORRECT ENTRY
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1