MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 360060

Device Problems Component Incompatible (1108); Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that during use with a bd tube sst plh 13x100 5.0 plbl gold br the tube would under fill and the tube is difficult to attach in holder.The following information was provided by the initial reporter, translated from (b)(6) to english: serum tubes showing the following problems: lack of vacuum and difficulty adapting the tube to the holder (the tube does not attach).

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-10-20.H6: investigation summary: bd received 9 samples from the customer for investigation.4 samples were evaluated by draw testing and the indicated failure mode for incorrect assembly and underfill with the incident lot was not observed as all product specifications were met.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.

Event Description

It was reported that during use with a bd tube sst plh 13x100 5.0 plbl gold br the tube would under fill and the tube is difficult to attach in holder.The following information was provided by the initial reporter, translated from portuguese to english: serum tubes showing the following problems: lack of vacuum and difficulty adapting the tube to the holder (the tube does not attach).

• Brand Name: BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 10645476
• MDR Text Key: 244149856
• Report Number: 3003916417-2020-00298
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 360060
• Device Lot Number: 9341817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other