MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE; SPECIMEN COLLECTION TUBE

Catalog Number 362760

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample or photo is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that a bd vacutainer® cpt¿ mononuclear cell preparation tube - sodium citrate  (13x100 mm / 4ml) tubes were breaking during centrifugation.

• Brand Name: BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE
• Type of Device: SPECIMEN COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6984221
• MDR Text Key: 91206191
• Report Number: 1917413-2017-00263
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 50382903627603
• UDI-Public: 50382903627603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

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 Catalogue Number: 362760
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 10/27/2017
• 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