MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368660
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2020
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.(b)(4).
Event or Problem Description
It was reported that hair was discovered in tube with a bd vacutainer® serum blood collection tubes.The following information was provided by the initial reporter: it was reported that there was hair on the tube.
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples, but two (2) photos were returned from the customer facility for evaluation.The photos do show the customer¿s failure mode of ¿fm¿ (foreign matter) with debris and hair on the product.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 or Problem Description
It was reported that hair was discovered in tube prior to use with a bd vacutainer® serum blood collection tubes.The following information was provided by the initial reporter: it was reported that there was hair on the tube.
Event or Problem Description
It was reported that hair was discovered in tube prior to use with a bd vacutainer® serum blood collection tubes.The following information was provided by the initial reporter: it was reported that there was hair on the tube.
Additional Manufacturer Narrative
The following fields have been updated with additional information: b.3.Date of event: (b)(6) 2020.B.5.Describe event or problem: it was reported that hair was discovered in tube prior to use with a bd vacutainer® serum blood collection tubes.The following information was provided by the initial reporter: it was reported that there was hair on the tube.

• Brand Name: BD VACUTAINER SERUM BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10718612
• Report Number: 1917413-2020-00985
• Device Sequence Number: 1902363
• Product Code: JKA
• UDI-Device Identifier: 50382903686600
• UDI-Public: 50382903686600
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 368660
• Device Catalogue Number: 368660
• Device Lot Number: 9344022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 11/24/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/06/2020; 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1