MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ HEPARIN LOCK FLUSH SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Missing Information (4053)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported that the unspecified bd¿ heparin lock flush syringe had no drug information label on it.The following information was provided by the initial reporter: "i would like to report a bd heparin lock flush 10u/ml 3ml syringe that was found with no drug information label".

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Pr (b)(4) follow up for device evaluation.It was reported a bd heparin lock flush was found without the label.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe in its packaging flow wrap that is missing the syringe barrel label.No other defects or imperfections were observed.This defect could occur if there was a jam during the labeling process.As the material and lot number provided are 'unknown,' a device history record review could not be completed.Verification of the labeling process was performed.The settings were correct, and the flow of product was good.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

Event Description

No additional information received mat#: unknown lot#: unknown.It was reported by customer that bd heparin lock flush 10u/ml 3ml syringe that was found with no drug information label (pictured below).Verbatim: complaint received via email.Email(s) attached.Question i would like to report a bd heparin lock flush 10u/ml 3ml syringe that was found with no drug informationlabel (pictured below).Unfortunately, we do not have the lot of the syringe or the original box it came in sinceit was found in the pyxis machine.We checked all syringes in stock and did not find any more with missinglabels.Please advise on next steps or if you have any questions.

• Brand Name: UNSPECIFIED BD¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17837267
• MDR Text Key: 324936634
• Report Number: 2243072-2023-01739
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1