MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) TUBE SST II PLH 13X100 5.0 PLBL CE NAT; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368970

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

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 after use the tube sst ii plh 13x100 5.0 plbl ce nat experienced erroneous results.The following information was provided by the initial reporter: "the patient performed the sampling at the laboratory, the creatinine was high and for this reason the laboratory immediately sent the patient for hospital check.Analysis has been repeated and result was normal.Re-done the next day at the laboratory creatinine was normal.Retested creatinine from the tube taken on the first day, this has always been high creatinine.".

Event Description

It was reported after use the tube sst ii plh 13x100 5.0 plbl ce nat experienced erroneous results.The following information was provided by the initial reporter: "the patient performed the sampling at the laboratory, the creatinine was high and for this reason the laboratory immediately sent the patient for hospital check.Analysis has been repeated and result was normal.Re-done the next day at the laboratory creatinine was normal.Retested creatinine from the tube taken on the first day, this has always been high creatinine.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-04-29 h6: investigation summary bd received 100 samples from the customer for investigation.10 customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and were found acceptable in terms of both precision and accuracy.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.Additive preparation and dispense was carried out with no issues relating to the reported defect being identified.H3 other text : see h.10.

• Brand Name: TUBE SST II PLH 13X100 5.0 PLBL CE NAT
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 9988227
• MDR Text Key: 189181404
• Report Number: 9617032-2020-00357
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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: 02/28/2021
• Device Catalogue Number: 368970
• Device Lot Number: 9235353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other