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

Model Number 306424

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported that the syringe was missing the label.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.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.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 Description

It was reported that the syringe 5ml heparin 100 unit had no label 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.".

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.

Event Description

It was reported that the syringe 5ml heparin (b)(4) unit had no label 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.".

• Brand Name: BD SYRINGE 5ML HEPARIN 100 UNIT
• Type of Device: HEPARIN VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12455195
• MDR Text Key: 271496908
• Report Number: 1911916-2021-00977
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (y/n): N
• PMA/PMN Number: K163591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1