MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20G X 19MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SHG20-75
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redx3823 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the needle was attached to a patient receiving treatment when the patient noticed that her shoulder was wet.On close examination, the line has a very small hole in it which was causing a leakage.Fortunately this happened very early on receiving treatment, so the patient most likely wasn¿t exposed to the agent being given.
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, 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 a leaking infusion set was confirmed and the cause appears to be use related.The product returned for evaluation was one 20ga x 0.75" ez huber safety infusion set.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed in the extension tubing, near the needle housing.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the needle was attached to a patient receiving treatment when the patient noticed that her shoulder was wet.On close examination, the line has a very small hole in it which was causing a leakage.Fortunately this happened very early on receiving treatment, so the patient most likely wasn¿t exposed to the agent being given.

• Brand Name: EZ HUBER 20G X 19MM
• 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: 10788111
• Report Number: 3006260740-2020-20380
• Device Sequence Number: 14486931
• Product Code: FPA
• UDI-Device Identifier: 00801741089237
• UDI-Public: (01)00801741089237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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 Expiration Date: 09/30/2022
• Device Model Number: SHG20-75
• Device Catalogue Number: SHG20-75
• Device Lot Number: REDX3823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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