MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA W/PRN PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383335
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd saf-t-intima w/prn pink 20ga x 1.0in leaked the following information was provided by the initial reporter: at 10:45 on (b)(6) 2024, in the songshan lake urological surgery ward, the patient had an indwelling needle placed in his hand before the operation.When the needle was successfully withdrawn and the needle was successfully inserted, the needle wing was disconnected from the extension tube, and blood oozed from the fracture of the needle wing, so he immediately pulled it out.Needle, press the needle port to stop the bleeding, perform a second puncture to appease the patient, and then report the medical device adverse events to the head nurse for follow-up.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo and 1 sample submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the sample.Analysis of the sample showed that the tubing was separated from the wing and a lack of adhesive was present.Bd determined that the cause of the failure was related to our manufacturing process.However, further actions cannot be taken since the production of this product has been moved to a different manufacturing facility.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.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
No additional information received.

• Brand Name: BD SAF-T-INTIMA W/PRN PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• 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: 18696801
• Report Number: 9610847-2024-00027
• Device Sequence Number: 17923847
• Product Code: FOZ
• UDI-Device Identifier: 30382903833352
• UDI-Public: (01)30382903833352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 383335
• Device Lot Number: 2146213
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown