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

Catalog Number 309620

Device Problems Failure to Deliver (2338); Physical Resistance/Sticking (4012)

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

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Investigation summary : 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 investigation conclusion : based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description : undetermined rationale : no batch#/sample available.

Event Description

It was reported that bd¿ catheter tip syringe the plunger is getting stuck when pushed on so it will not release any liquid.No serious injury or medical intervention was reported.

Manufacturer Narrative

Device returned to manufacturer is corrected to yes.

Event Description

It was reported that bd¿ catheter tip syringe the plunger is getting stuck when pushed on so it will not release any liquid.No serious injury or medical intervention was reported.

• Brand Name: BD¿ CATHETER TIP SYRINGE
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7906401
• MDR Text Key: 121746367
• Report Number: 1911916-2018-00538
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other