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 Problem Material Twisted/Bent (2981)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of asezf016 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the safety mechanism could not be put down all the way.It meets resistance and the needle also appears bent.No other information was provided.

Event Description

It was reported that the safety mechanism could not be put down all the way.It meets resistance and the needle also appears 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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent needle was confirmed but the exact cause remains unknown.The product returned for evaluation was one 20 g x 0.75 in.Safestep infusion set.The returned product sample was evaluated, and the needle was observed to be bent about 0.8 cm from its base.The following observations were noted during the sample evaluation: the needle was bent at the region where the needle extends from the base.Microscopic examination of the sample found no supporting evidence of a specific root cause.Based on the evidence provided with the returned sample it is unknown when or how the bend occurred in the needle.Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product; however, no evidence was observed which supported a specific root cause of the event.H3 other text : evaluation findings are in section h.11.

• 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: 11682706
• MDR Text Key: 246285351
• Report Number: 3006260740-2021-01405
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: ASEZF016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other