MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE¿ 5ML HEPARIN 100 UNIT; INTRAVASCULAR CATHETER

Catalog Number 306424

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd syringe¿ 5ml heparin 100 unit packages do not have barcodes on them.Verbatim: health professional called to report that they found two boxes where the syringe packages did not have barcode so they are unable to scan them into their inventory.Lot 827576n found "the other day" and lot 827573n found "today".She might be able to provide photos.She wonders if this is a permanent change.No patient involvement, before use.

Manufacturer Narrative

Correction: the information was re-evaluated and the complaint does not meet our mdr reporting criteria.

Event Description

It was reported that bd syringe¿ 5ml heparin 100 unit packages do not have barcodes on them.Verbatim: health professional called to report that they found two boxes where the syringe packages did not have barcode so they are unable to scan them into their inventory.Lot 827576n found "the other day" and lot 827573n found "today".She might be able to provide photos.She wonders if this is a permanent change.No patient involvement, before use.

Event Description

It was reported that bd syringe¿ 5ml heparin 100 unit packages do not have barcodes on them.Verbatim: health professional called to report that they found two boxes where the syringe packages did not have barcode so they are unable to scan them into their inventory.Lot 827576n found "the other day" and lot 827573n found "today".She might be able to provide photos.She wonders if this is a permanent change.No patient involvement, before use.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD SYRINGE¿ 5ML HEPARIN 100 UNIT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8429466
• MDR Text Key: 139191928
• Report Number: 1911916-2019-00278
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 306424
• Device Lot Number: 827573N
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other