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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported blood withdrawal via port, after the blood withdrawal was finished and the tube was flushed and blocked with positive pressure, a drop of blood was hanging at the transition from tube to needle.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz3339 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz3339 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported blood withdrawal via port, after the blood withdrawal was finished and the tube was flushed and blocked with positive pressure, a drop of blood was hanging at the transition from tube to needle.
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.A lot history review (lhr) of reez3339 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported blood withdrawal via port, after the blood withdrawal was finished and the tube was flushed and blocked with positive pressure, a drop of blood was hanging at the transition from tube to needle.
Event or Problem Description
It was reported blood withdrawal via port, after the blood withdrawal was finished and the tube was flushed and blocked with positive pressure, a drop of blood was hanging at the transition from tube to needle.
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, and applicable manufacturing records.Based on a review of this information, the following was concluded: the complaint of a leak in the infusion set was confirmed and the cause appeared to be associated with the manufacturing process.One ez huber infusion set was returned for investigation.The sample exhibited evidence of use.A functional test revealed fluid leaking from the interface between the extension set tubing and the needle housing.A microscopic examination of the leak site revealed variation in the adhesive bond between the extension set tubing and the needle housing.The leak appears to be associated with the breach in the adhesive bond between the tubing and the needle housing.Bd is working closely with manufacturing to prevent recurrence of the reported event.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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13544290
• Report Number: 3006260740-2022-00345
• Device Sequence Number: 12066049
• Product Code: FPA
• UDI-Device Identifier: 00801741089169
• UDI-Public: (01)00801741089169
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 04/19/2022

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: REEZ3339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 04/19/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/03/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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