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

Catalog Number 306424

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the (b)(6) label and insert was missing with a bd syr 5ml surescrub posiflush 100u heparin.This occurred on 120 separate occasions.The following information was provided by the initial reporter: missing label in (b)(6) language in the box and inside of it.The posiflush prefilled syringe box does not carry the counter-label in (b)(6) of nationalization.The instruction comes in english.Customer says that previous lots came with (b)(6) labeling.

Manufacturer Narrative

Investigation: six photos were provided showing the shelf box and the instructions for use.They all are according to our manufacturing specification.The spanish relabeling nationalization occurs at some point during the supply chain, not at the manufacturing site.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.

Event Description

It was reported that the spanish label and insert was missing with a bd syr 5ml surescrub posiflush 100u heparin.This occurred on 120 separate occasions.The following information was provided by the initial reporter, translated from spanish to english: missing label in spanish language in the box and inside of it.The posiflush prefilled syringe box does not carry the counter-label in spanish of nationalization.The instruction comes in english.Customer says that previous lots came with spanish labeling.

Event Description

It was reported that the spanish label and insert was missing with a bd syringe 5ml heparin.This occurred on 120 separate occasions.The following information was provided by the initial reporter, translated from spanish to english: missing label in spanish language in the box and inside of it.The posiflush prefilled syringe box does not carry the counter-label in spanish of nationalization.The instruction comes in english.Customer says that previous lots came with spanish labeling.

Manufacturer Narrative

The following fields have been updated with additional/corrected information: b.5.Describe event or problem: it was reported that the spanish label and insert was missing with a bd syringe 5ml heparin.This occurred on 120 separate occasions.The following information was provided by the initial reporter, translated from spanish to english: missing label in spanish language in the box and inside of it.The posiflush prefilled syringe box does not carry the counter-label in spanish of nationalization.The instruction comes in english.Customer says that previous lots came with spanish labeling.D.1.Medical device brand name: bd syringe 5ml heparin.D.1 medical device type: nzw.D.2.Common device name: heparin, vascular access flush.D.4 medical device catalog #: 306424.D.4.Medical device lot #: 827572n.D.4.Medical device expiration date: 2020-09-30.D.4.Unique identifier (udi) #: (b)(4).G.5.Pma / 510(k)#: k090680.

• Brand Name: BD SYRINGE 5ML HEPARIN
• 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: 8818109
• MDR Text Key: 152066948
• Report Number: 1911916-2019-00726
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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: 827572N
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other