MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number LH-0031

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported by the customer we have encountered another event related to the same issue.It was, however, a different lot number.I have the device in my possession.No patient harm noted.No other information was provided.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Based on a review of this information, the following was concluded: the complaint of difficulty activating the safety mechanism of infusion sets is confirmed and was determined to be supplier related.Four 20 ga x 0.75 in.Safestep infusion sets were returned for evaluation.Microscopic observations of the returned infusion sets revealed the first three samples exhibited excessive adhesive where the metal collar of the safety mechanism meets with the needle housing.Functional testing of attempting to engage the safety mechanism of each of the four samples revealed the first three samples to exhibit difficulty engaging the safety mechanism.Engaging the safety mechanism for sample 4 was unremarkable.Because excessive adhesive was found on the metal collar of 3 out of the 4 returned safety mechanisms, preventing the safety to be engaged, the complaint of difficulty engaging the safety mechanisms of the returned samples is confirmed.This complaint will be recorded for future trending and monitoring purposes.The supplier was notified of this event and bd is working closely with the supplier to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h11.

Event Description

It was reported by the customer we have encountered another event related to the same issue.It was, however, a different lot number.I have the device in my possession.No patient harm noted.No other information was provided.10/30/2023 - 4 devices were returned for investigation, 3 of them confirmed the reported issue.This report addresses the first confirmed device.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17007908
• MDR Text Key: 316009382
• Report Number: 3006260740-2023-02119
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LH-0031
• Device Lot Number: ASGSFC087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other