MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE CATHETER TIP 60ML; IRRIGATING SYRINGE

Model Number 309620

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2020

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.The customer's address is unknown.(b)(6) has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that syringe catheter tip 60ml had foreign matter on 2 occasions before use.The following information was provided by the initial reporter: material no: 309620 batch no: unknown.It was reported that the product was dirty / stained.

Event Description

It was reported that syringe catheter tip 60ml had foreign matter on 2 occasions before use.The following information was provided by the initial reporter: material no: 309620 batch no: unknown.It was reported that the product was dirty / stained.

Manufacturer Narrative

Investigation summary: no sample was received for investigation.18 photos were provided and 17 of them show products that are not manufactured at this site.One photo shows a needle assembly with the plastic shield.The plastic shield has embedded degraded resin.No sample was received.No photo related to the symptom was provided.Therefore, sample analysis could not be performed, and the condition reported by the customer could not be confirmed.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

• Brand Name: SYRINGE CATHETER TIP 60ML
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10424674
• MDR Text Key: 204727831
• Report Number: 1911916-2020-00771
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other