MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD TUBE GLU PLH 13X100 6.0 PLBL GR; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367925
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd tube glu plh 13x100 6.0 plbl gr there was incorrect label information.The following information was provided by the initial reporter.The customer stated: we received product labeled as 367925; however, the tubes were actually material 367886.
Event or Problem Description
It was reported when using the bd tube glu plh 13x100 6.0 plbl gr there was incorrect label information.The following information was provided by the initial reporter.The customer stated: we received product labeled as 367925; however, the tubes were actually material 367886.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 2 photos from the customer in support of this complaint.A visual examination of photos was performed and revealed an incorrect shelf label.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.Bd determined the root cause of the incorrect shelf label was attributed to operator error.The device history records for both lots were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
Additional Manufacturer Narrative
H.3.Investigation summary: bd received 2 photos from the customer in support of this complaint.The photo revealed a single bd vacutainer® heparin shelf pack had a bd vacutainer® fluoride label applied.The tubes inside the shelf pack had the correct tube unit label applied showing bd vacutainer® heparin, catalog 367886, lot no.2166068.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.Bd determined the root cause of the incorrect shelf label was attributed to operator error.From the investigation performed, the operator reworking the rejected shelf pack manually affixed an incorrect label to only one shelf pack.Furthermore, with the defect affecting one shelf pack, our inspection level remains within aql levels.The investigation revealed that only one unit is impacted, and the labeling defect was identified at the shelf pack level only.Therefore, no further action is required at this time.The device history records for both lots were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
Event or Problem Description
It was reported when using the bd tube glu plh 13x100 6.0 plbl gr there was incorrect label information.The following information was provided by the initial reporter.The customer stated: we received product labeled as 367925; however, the tubes were actually material 367886.

• Brand Name: BD TUBE GLU PLH 13X100 6.0 PLBL GR
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15474165
• Report Number: 1917413-2022-00599
• Device Sequence Number: 2892171
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2022

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: 10/31/2023
• Device Model Number: 367925
• Device Catalogue Number: 367925
• Device Lot Number: 2132113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/14/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/27/2022; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown