MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS1 360 WHITE BLEND; STOPCOCK, I.V. SET

Catalog Number	394910
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd connecta plus1 360 white blend had cracks the following information was provided by the initial reporter; it was reported by the customer that there were cracks in the stopcocks.Verbatim: we have received product with cracks in the stopcocks.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 3 photos and 1 physical sample submitted for evaluation.The reported issue of crack with leak was not confirmed upon inspection of the samples.Analysis of the sample and photos showed that it is not a bd product and therefore no further investigation could be performed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
Material #: 394910 , batch #: 2276782.It was reported by the customer that there were cracks in the stopcocks.Verbatim: we have received product with cracks in the stopcocks response received on 08-nov-2023: 1.Are you able to provide the quantity of defective stopcocks involved? yes, sent 1 back today.2.Please confirm if there was any patient involvement? yes.3.Was this noted before use or during use? it was actively in use on a patient.Response received on 16-nov-2023: 1.Could you please confirm if there was any adverse event or serious injury involved? none.2.What was the patient outcome? n/a.3.What type of procedure was being performed? none.Stopcock started leaking independently.4.Was the procedure completed as planned? how was it resolved? n/a.

• Brand Name: BD CONNECTA PLUS1 360 WHITE BLEND
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18229200
• Report Number: 9610847-2023-00341
• Device Sequence Number: 17543071
• Product Code: FMG
• UDI-Device Identifier: 00382903949106
• UDI-Public: (01)00382903949106
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K974083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 09/30/2025
• Device Catalogue Number: 394910
• Device Lot Number: 2276782
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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