MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; HEPARIN, VASCULAR ACCESS FLUSH

Model Number	306424
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd 5 ml bd posiflush¿ heparin lock flush syringe pluger rod was damaged.The following information was provided by the initial reporter: the syringe came with a defective plunger.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?yes.D10: returned to manufacturer on: 11-oct-2022 h6: investigation summary it was reported the syringe came with a defective plunger.To aid in the investigation, one empty sample with no packaging flow wrap and three photos were provided for evaluation by our quality team.A visual inspection was performed and the top part of the plunger rod is damaged.The photos show a syringe with no packaging flow wrap.The top part of the plunger rod is damaged.No other defects or imperfections were observed.This defect could occur if the product was caught between knives due to incorrect product spacing during the packaging flow wrap process.A device history record review was completed for provided material number 306424, lot number 122987n.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the flow wrap packaging process was performed.The settings were correct and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
It was reported that the bd 5 ml bd posiflush¿ heparin lock flush syringe pluger rod was damaged.The following information was provided by the initial reporter: the syringe came with a defective plunger.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15587874
• Report Number: 1911916-2022-00565
• Device Sequence Number: 20627858
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: (01)30382903064244
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 306424
• Device Catalogue Number: 306424
• Device Lot Number: 122987N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown