MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20G X 25MM; 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	02/02/2022
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 refv1741 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the needle was pulled, the safety mechanism disengaged from the retaining plate.This means there is a risk that employees will poke themselves or that chemotherapy drugs will leak out unintentionally.The defective needle was discarded.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refv1741 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the needle was pulled, the safety mechanism disengaged from the retaining plate.This means there is a risk that employees will poke themselves or that chemotherapy drugs will leak out unintentionally.The defective needle was discarded.
Event or Problem Description
It was reported that when the needle was pulled, the safety mechanism disengaged from the retaining plate.This means there is a risk that employees will poke themselves or that chemotherapy drugs will leak out unintentionally.The defective needle was discarded.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached safety mechanism is confirmed; however, the exact cause is unknown.One photograph of a powerloc ez infusion set was returned for evaluation.An initial visual observation of the photograph showed the safety mechanism of the infusion set was completely detached.A clear liquid could be seen within the infusion set tubing, but no blood residue could be seen on the sample in the returned photograph.The biobag of the safety mechanism was observed to be slightly crumpled, but no details of the break surfaces could be seen in the returned photograph.While a detached safety mechanism can be confirmed from the returned photograph, the evidence that could be seen in the returned photograph was insufficient to identify the root cause of the damage.However, possible causes include sharp instrument damage, material damage or variation, and excessive force used during activation of the safety mechanism.H3 other text : evaluation findings are in section h.11.

• Brand Name: EZ HUBER 20G X 25MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13602267
• Report Number: 3006260740-2022-00502
• Device Sequence Number: 5856782
• Product Code: FPA
• UDI-Device Identifier: 00801741089169
• UDI-Public: (01)00801741089169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: SHG20-100
• Device Lot Number: REFV1741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown