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

Catalog Number	306424
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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.
Additional Manufacturer Narrative
Correction: the information was re-evaluated and the complaint does not meet our mdr reporting criteria.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8429466
• Report Number: 1911916-2019-00278
• Device Sequence Number: 1253597
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 306424
• Device Lot Number: 827573N
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019; 03/01/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 03/25/2019; 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other