MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBE EXTENDER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365976
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 extenders are too tight with an bd microtainer® tube extender.The following information was provided by the initial reporter: it was reported that extenders are too tight.The extender can be pushed into the microtainer, but it is difficult, and the techs are complaining that the repetitive motion hurts their wrists, so they use a small hammer to push the extender into the microtainer.
Event or Problem Description
It was reported that the extenders are too tight with an bd microtainer® tube extender.The following information was provided by the initial reporter: it was reported that extenders are too tight.The extender can be pushed into the microtainer, but it is difficult, and the techs are complaining that the repetitive motion hurts their wrists, so they use a small hammer to push the extender into the microtainer.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to overly tight extenders 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.H3 other text : see h.10.

• Brand Name: BD MICROTAINER® TUBE EXTENDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9774846
• Report Number: 2618282-2020-00013
• Device Sequence Number: 526778
• Product Code: JKA
• UDI-Device Identifier: 50382903659765
• UDI-Public: 50382903659765
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K931368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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 Model Number: 365976
• Device Catalogue Number: 365976
• Device Lot Number: 9302569
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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