MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE; CELL PREP TUBE

Catalog Number 362753

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2016

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.Result: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for breakage with the incident lot was observed.A review of the manufacturing records was completed for the incident lot # 5105880 and no issues were identified.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 16x125 mm., 8.0 ml.Bd vacutainer® cpt glass molecular diagnostics tube.Green/red conventional closure.See thru label.Additive: density gradient polymer gel and sodium heparin for mononuclear cell preparation, broke during centrifugation.No injury or medical intervention.

• Brand Name: BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE
• Type of Device: CELL PREP 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: 7058841
• MDR Text Key: 93611299
• Report Number: 1917413-2017-00355
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 00382903627530
• UDI-Public: 00382903627530
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362753
• Device Lot Number: 5105880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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