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

Model Number	306413
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that scale markings were missing on the bd posiflush¿ heparin lock flush syringe.This event occurred 2 times.The following information was provided by the initial reporter: once they took the syringe out from the wrapper, the inner syringe was unlabeled.
Event or Problem Description
It was reported that scale markings were missing on the bd posiflush¿ heparin lock flush syringe.This event occurred 2 times.The following information was provided by the initial reporter: once they took the syringe out from the wrapper, the inner syringe was unlabeled.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 01-apr-2022.Possible lot numbers.D4: medical device lot #: 129482n.D4: medical device lot #: 131833n.D4: medical device expiration date: 30-apr-2023.H4: device manufacture date: 25-feb-2022.H6: investigation summary: it was reported the inner syringe was unlabeled.To aid in the investigation, three samples were received for evaluation by our quality team.A visual inspection was performed.One sample has no syringe barrel label.No other defects or imperfections were observed.This defect could occur if there was a jam at the labeler machine inducing the missing syringe barrel label.For the 'unknown' lot provided a device history record review could not be completed.A device history record review was completed for additional lot numbers 129482n and 131833n.The review did not reveal any detected quality issues during the production these lots that could have contributed to the reported defect.Verification of the labeler machine was performed.The settings were correct and the flow of products was good.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• 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: 13893198
• Report Number: 1911916-2022-00166
• Device Sequence Number: 12351616
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: 30382903064138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Model Number: 306413
• Device Catalogue Number: 306413
• Device Lot Number: SEE H10
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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