MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to activate the safety mechanism is inconclusive due to poor sample condition.One photo sample of a 22 ga x 0.75 in safestep infusion set was returned for investigation.The product packaging was shown with lot: asdvs0125.The infusion set is shown to be within a plastic container.The safety mechanism is not shown to be fully activated but appears to be slightly advanced.The condition and potential issues with the device could not be clearly investigated.Based on the description of the reported event, possible contributing factors include bent needle and excessive adhesive applied during manufacturing.Since the complaint could not be confirmed from the photo sample provided, the complaint is inconclusive.A lot history review (lhr) of asdvs0125 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after use on the patient, the needle was found fail to retract into the metal sleeve.No other information was provided.

Event Description

It was reported that after use on the patient, the needle was found fail to retract into the metal sleeve.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 activation difficulty 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.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.A lot history review (lhr) of asdvs0125 showed no other similar product complaint(s) from this lot number.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9876079
• MDR Text Key: 194531480
• Report Number: 3006260740-2020-00978
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• 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
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0029
• Device Lot Number: ASDVS0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1