MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML HEPARIN 100 UNIT; HEPARIN VASCULAR ACCESS FLUSH

Model Number	306424
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported that the syringe was missing the scale markings.To aid in the investigation, two photos were provided for evaluation by our quality team.No text or any other information is printed on the syringe barrel.A device history record review was completed for provided material number 306424, lot number 106026n.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the syringe 5ml heparin 100 unit had no scale markings on it.The following information was provided by the initial reporter: "i would just like to bring to your attention that we have received some syringes of heparin lock flush and we noticed that 1 of the syringes was missing a label as well as any calibration that is usually printed on the physical syringe.".
Event or Problem Description
It was reported that the syringe 5ml heparin 100 unit had no scale markings on it.The following information was provided by the initial reporter: "i would just like to bring to your attention that we have received some syringes of heparin lock flush and we noticed that 1 of the syringes was missing a label as well as any calibration that is usually printed on the physical syringe.".
Additional Manufacturer Narrative
H.6.Investigation: it was reported that the syringe was missing the label and scale markings.To aid in the investigation, two photos were provided for evaluation by our quality team.Both photos show one syringe with a barrel label and the another syringe without it.This defect can occur if there was a jam during the labeling process inducing the unit being missed when applying the syringe barrel label.The syringe barrel label has all the information including the graduation scale.No text or any other information is printed on the syringe barrel.A device history record review was completed for provided material number 306424, lot number 106026n.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Verification of the labeling process was performed.Settings and alignment of the label feeder was correct.Product flow was acceptable.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h.10.

• Brand Name: BD SYRINGE 5ML HEPARIN 100 UNIT
• Common Device Name: HEPARIN VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12455293
• Report Number: 1911916-2021-00976
• Device Sequence Number: 17134767
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 03/31/2023
• Device Model Number: 306424
• Device Catalogue Number: 306424
• Device Lot Number: 106026N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1