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 Fracture (1260); Separation Problem (4043)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

It was reported when using the bd tube sst plh 13x100 5.0 plbl gold br the stopper popped out of the tube, there was glass breakage during use, and the stopper pulled out of the tube when in an analyzer.The stopper pop out event occurred 20 times.The glass breakage event occurred 20 times the stopper pop off during centrifugation event occurred 20 times.The following information was provided by the initial reporter.The customer stated: identified occurrence of tubes break, stoppers pop off and displacement issues, spillage and accidents, culminating in high rates of blood recollection.Intercurrences happen in batches 2090432 and 2181405.Rows 1, 2, 3 & 4: stopper pop off / glass breakage for both batches with no specific date of event.Customer reports 10% of frequency (10% considered for a shelf pack) attached file from interface attachment(s) field is the technical report: high rate of intercurrences, such as tubes break, stoppers pop off and stoppers displacement issues, spillage and accidents, which has resulted in high rates of blood recollection.We estimate that the frequency of these occurrences is about 10%.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2090432.Medical device expiration date: 2023-03-31.Device manufacture date: 2022-05-12.Medical device lot #: 2181405.Medical device expiration date: 2023-06-30.Device manufacture date: 2022-07-21.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but eight (8) photos were provided for investigation.The photos were reviewed and the indicated failure mode for stopper pop off or breakage with the incident lot was not observed.Additionally, two hundred (200) retention samples from each lot were evaluated by visual examination and no issues were observed relating to stopper pop off or breakage as all samples met specifications.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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd tube sst plh 13x100 5.0 plbl gold br the stopper popped out of the tube, there was glass breakage during use, and the stopper pulled out of the tube when in an analyzer.The stopper pop out event occurred 20 times.The glass breakage event occurred 20 times the stopper pop off during centrifugation event occurred 20 times.The following information was provided by the initial reporter.The customer stated: identified occurrence of tubes break, stoppers pop off and displacement issues, spillage and accidents, culminating in high rates of blood recollection.Intercurrences happen in batches 2090432 and 2181405.Rows 1, 2, 3 & 4: stopper pop off / glass breakage for both batches with no specific date of event.Customer reports 10% of frequency (10% considered for a shelf pack) attached file from interface attachment(s) field is the technical report: high rate of intercurrences, such as tubes break, stoppers pop off and stoppers displacement issues, spillage and accidents, which has resulted in high rates of blood recollection.We estimate that the frequency of these occurrences is about 10%.

• 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
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15814490
• MDR Text Key: 307204841
• Report Number: 3003916417-2022-00257
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 360060
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• 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