MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 2 OZ. 60 ML BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE

Catalog Number 309620

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the clinician found a reddish-brown discoloration and particulate matter in a 2 oz.60 ml bd¿ catheter tip syringe before use.No injury or medical intervention.

Manufacturer Narrative

Investigation results: a sample was sent to bd, however we are unable to locate it at this time.Please understand this is a rare occurrence.Should the sample be located we will re-investigate.A dhr was completed and no defects were found.No quality notifications were issued for this batch.Root cause is undetermined.Capa not necessary.

• Brand Name: 2 OZ. 60 ML 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: 6966796
• MDR Text Key: 90763314
• Report Number: 1911916-2017-00278
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 309620
• Device Lot Number: 7086720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2017
• 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