MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD MICROTAINER® SST¿; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365967
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the labels are peeling off with a bd microtainer® sst¿.The following information was provided by the initial reporter: it was reported that the labels have been peeling off for the past six months.Additional information received from customer: all products feel ¿slippery¿.Are any other tubes affected? if yes, please provide the catalog reference and lot number.We test vacutainers, other glass and plastic tube types and none are displaying labels lifting off like the microtainers are.Are any images available showing the lifting labels? new label stock and old label stock retested to rule out it being a label issue.
Additional Manufacturer Narrative
H.6 investigation summary : 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 incorrect/missing label information with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, no issues were observed relating to incorrect/missing label information as all samples met specifications.A review of the device history record was completed for the incident lot 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.
Event or Problem Description
It was reported that the labels are peeling off with a bd microtainer® sst¿.The following information was provided by the initial reporter: it was reported that the labels have been peeling off for the past six months.Additional information received from customer: all products feel ¿slippery¿.Are any other tubes affected? if yes, please provide the catalog reference and lot number.We test vacutainers, other glass and plastic tube types and none are displaying labels lifting off like the microtainers are.Are any images available showing the lifting labels? new label stock and old label stock retested to rule out it being a label issue.

• Brand Name: BD MICROTAINER® SST¿
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 9836572
• Report Number: 9614033-2020-00030
• Device Sequence Number: 11621897
• Product Code: JKA
• UDI-Device Identifier: 50382903659673
• UDI-Public: 50382903659673
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2020
• Device Model Number: 365967
• Device Catalogue Number: 365967
• Device Lot Number: 9058759
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other