MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reex0002 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "can¿t active safety mechanism.Remove with unsafely way.".
Additional 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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of an issue with the safety mechanism is confirmed and appears to be manufacturing related.One 20 ga x 0.75 in huber plus infusion set was returned.The product label included indicated lot: reex0002.The safety mechanism has not been activated.An attempt to activate the safety mechanism was unsuccessful.The safety appeared to experience a tolerance fit issue.Microscopic observation of the safety mechanism and needle shaft revealed material to be present on the needle.The material was found to be the source of the resistance experienced when attempting to advance the safety.The material appeared to resemble the adhesive used in the manufacturing process; therefore, the complaint is confirmed.Bd is working closely with the manufacturer to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that "can¿t active safety mechanism.Remove with unsafety way." no other information was provided.

• Brand Name: HUBER PLUS 20G X 0.75"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11783290
• Report Number: 3006260740-2021-01689
• Device Sequence Number: 3722143
• Product Code: FPA
• UDI-Device Identifier: 00801741065620
• UDI-Public: (01)00801741065620
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 012034
• Device Lot Number: REEX0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other