MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0029YN

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that customer cannot safely remove this device.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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure to activate was confirmed; however, the root cause was not identified.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set with y-site.Usage residues were observed throughout the sample.The safety mechanism was not engaged.White residue was observed within the safety plate.Initial attempts to activate the safety mechanism were unsuccessful.The springs were immobile due to the adhered residue.Microscopic inspection of the sample confirmed the presence of residue within the safety mechanism which appeared to immobilize the springs.Spring mobility and successful safety activation was established through gentle manipulation.The residue observed within the safety mechanism initially prevented proper safety function; however, the source of the residue was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that customer cannot safely remove this device.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11578594
• MDR Text Key: 242682842
• Report Number: 3006260740-2021-01039
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• PMA/PMN Number: K040527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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
• Device Operator: Health Professional
• Device Model Number: LH-0029YN
• Device Catalogue Number: LH-0029YN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other