MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 3ML HEPARIN; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number 306413

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone #: unknown.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 when customer scanned product it stated the it was an "each" instead of "shelf pack" with a 5 ml bd luer-lok¿ syringe sterile, single use.

Manufacturer Narrative

Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.

Event Description

It was reported that when customer scanned product it stated the it was an "each" instead of "shelf pack" with a bd syringe 3ml heparin.The following information was provided by the initial reporter: it was reported that the customer is having a challenge scanning product 306413.States that the primary di should be the ¿each¿ level (b)(4) instead of the shelf pack level (b)(4).

Event Description

It was reported that when customer scanned product it stated the it was an "each" instead of "shelf pack" with a bd syringe 3ml heparin.The following information was provided by the initial reporter: it was reported that the customer is having a challenge scanning product 306413.States that the primary di should be the ¿each¿ level (00382903064137) instead of the shelf pack level (30382903064138).

Manufacturer Narrative

The following fields have been updated with corrected information: b.5.Describe event or problem: it was reported that when customer scanned product it stated the it was an "each" instead of "shelf pack" with a bd syringe 3ml heparin.The following information was provided by the initial reporter: it was reported that the customer is having a challenge scanning product 306413.States that the primary di should be the ¿each¿ level (00382903064137) instead of the shelf pack level (30382903064138).D.1.Medical device brand name: bd syringe 3ml heparin.D.1 medical device type: nzw.D.2.Common device name: heparin, vascular access flush.D.3.Medical device manufacturer: becton dickinson and company ¿ colombus, ne / 68601.D.4 medical device catalog #: 306413.G.2 manufacturing location: becton dickinson and company ¿ colombus, ne / 68601.G.5.Pma / 510(k)#: k090680.

• Brand Name: BD SYRINGE 3ML 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: 8977641
• MDR Text Key: 157403284
• Report Number: 1213809-2019-00912
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306413
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other