MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13X75 MM 2.4 ML BD VACUTAINER® GLASS PLASMA ESR TUBE; BLOOD COLLECTION TUBE

Catalog Number 369741

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration 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.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that a 13x75 mm 2.4 ml bd vacutainer® glass plasma esr tube exploded in the users hand during use.Medical intervention required.

Manufacturer Narrative

Investigation: investigation summary: bd had not received samples or photos from the customer facility for investigation; therefore, the customer¿s indicated failure mode of tube breakage with the incident lot was not observed.The lot number involved in these incidents could not be confirmed by the customer; therefore, potential lot numbers were investigated.Retention samples were selected from in-house inventory from the potential lots and inspected for damage and no issues were observed as all retention samples met specifications.A review of the device history record was completed for the potential incident lot numbers and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: as bd had not received a sample or photo from the customer facility for investigation, the customer¿s indicated failure mode of tube breakage with the incident lot was not observed.Retention samples were tested and all specifications were met.If samples are received in the future, this investigation shall be updated.Root cause description: based on the investigation, a root cause could not be determined.

• Brand Name: 13X75 MM 2.4 ML BD VACUTAINER® GLASS PLASMA ESR TUBE
• Type of Device: BLOOD 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: 6828356
• MDR Text Key: 83936192
• Report Number: 1917413-2017-00100
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 369741
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• 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): Required Intervention