MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CATHENA 24GX0.75IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386815
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 24gx0.75in winged bc safety mechanism will not activate.It was reported by customer that they started an iv with 24 g needle, and when they went to retract the needle into the safety sheath, it was stuck and would not retract.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2024.Site name/location: xxxxxx.Level of harm: no apparent harm ¿ close call.Ahs optional report to cmdsnet (health canada): yes.Incident details: i started an iv with 24 g needle, and when i went to retract the needle into the safety sheath, it was stuck and would not retract.I did manage to get it out with forceful wiggling and pulling, but the needle was exposed.Impact of incident: the iv was still okay, so no harm to the patient other than a little discomfort from wiggling the needle.Who was affected? patient.Device information: device name/description: catheter iv safety winged with multiguard 24gax0.75in cathena.Manufacturer: becton dickinson canada inc.Manufacturer code/model: 386815.Serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): unknown.Supplier: xxxxx.Supplier catalogue number: 333-386815.Was the device retained? no.
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
Material # 386815 batch # 3267040.It was reported by customer that they started an iv with 24 g needle, and when they went to retract the needle into the safety sheath, it was stuck and would not retract.Rcc received a complaint via email.Ahs mdip reference number (id): (b)(4) date of incident (yyyy-mm-dd): (b)(6)2024 site name/location: xxxxxx level of harm: no apparent harm ¿ close call ahs optional report to cmdsnet (health canada): yes incident details: i started an iv with 24 g needle, and when i went to retract the needle into the safety sheath, it was stuck and would not retract.I did manage to get it out with forceful wiggling and pulling, but the needle was exposed.Impact of incident: the iv was still okay, so no harm to the patient other than a little discomfort from wiggling the needle.Who was affected? patient device information device name/description: catheter iv safety winged with multiguard 24gax0.75in cathena manufacturer: becton dickinson canada inc manufacturer code/model: 386815 serial or lot number: (b)(6) device expiry date (yyyy-mm-dd): unknown supplier: xxxxx supplier catalogue number: 333-386815 was the device retained? no.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there are outgoing functional test and in-process functional test to check and detect safety activation failure.As no photo and sample is returned for evaluation, root cause could not be established.

• Brand Name: BD CATHENA 24GX0.75IN WINGED BC
• 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): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20026945
• Report Number: 2243072-2024-00911
• Device Sequence Number: 7476978
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: (01)00382903868155(11)231004(17)260930(10)3267040
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (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): 09/18/2024

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: 09/30/2026
• Device Catalogue Number: 386815
• Device Lot Number: 3267040
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown