MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20GX 0.75 W/ Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0031YN

Device Problems Material Deformation (2976); Activation Problem (4042)

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

Event Date 03/26/2021

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 the device would not allow the safety mechanism to be used.It was reported that they were able to safety the device but it was challenging and the needle appeared bent.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 difficulty activating the safety mechanism was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 22ga x 0.75" safestep safety infusion set.The returned product sample was evaluated and the needle was observed to be bent just distal of the non-engaged safety mechanism.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The needle tip was barbed suggesting contact between the needle and port base.The bend in the needle shaft caused resistance when attempting to advance the safety mechanism.The safety mechanism was successfully engaged; however, greater than typical effort was required when passing the metal sleeve past the bent region of the needle shaft.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported the device would not allow the safety mechanism to be used.It was reported that they were able to safety the device but it was challenging and the needle appeared bent.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20GX 0.75 W/ 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: 11686041
• MDR Text Key: 246276718
• Report Number: 3006260740-2021-01423
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• 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,other
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH-0031YN
• Device Catalogue Number: LH-0031YN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other