MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER LH 102 I.U. PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367885
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples, but photos were provided for investigation (material #367885, lot #unknown).The photos were reviewed and the indicated failure mode for curls of plastic inside the tube was observed.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 3 bd vacutainer® lh 102 i.U.Plus blood collection tubes contained foreign matter.The following information was provided by the initial reporter: "curls of plastic inside lihep tubes "a staff member raised that she was noticing lumps of plastic on the side of bd vacutainer tubes.I asked that she lookout for an example which she has done and pictures are attached, the particular tube used an example is a lihep 6.0 ml pst bd vacutainer tube.According to staff some tubes have a lump of plastic on the side, the particular one in the example has a flap of plastic and almost appear to have a delaminated area in the moulding.I am worried that this could potentially result in sampling issues as we sample directly from primary tubes and probes could be touching the plastic or having it block sample aspiration.Other issues may include premature triggering of clotting prior to activation of lihep."".

• Brand Name: BD VACUTAINER LH 102 I.U. PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11732800
• Report Number: 9617032-2021-00377
• Device Sequence Number: 17084977
• Product Code: JKA
• UDI-Device Identifier: 00382903678556
• UDI-Public: 00382903678556
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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 Catalogue Number: 367885
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1