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

Model Number N/A

Device Problems Material Twisted/Bent (2981); Activation Problem (4042)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the safety feature did not work when the needle was removed.There was no reported patient injury.

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 but the exact cause remains unknown.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 mechansim.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 the safety mechanism was successfully engaged; however, resistance was encountered when advancing the metal sleeve over the bent region of the needle shaft.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, and no evidence was observed which supported a specific root cause of the event.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the safety feature did not work when the needle was removed.There was no reported patient injury.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN 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: 11424075
• MDR Text Key: 239734998
• Report Number: 3006260740-2021-00665
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0029YN
• Device Lot Number: ASDVS0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other