MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER, 4F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	03/24/2020
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 redv3533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "we had a dilator in the custom kit with sharp edges on it.When the inserter tried to break the dilator she was ¿poked¿ by something razor sharp.Upon assessment it was noticed that the dilator had a piece of plastic sticking straight up where the bard imprint is on the dilator.The inserter changed her gloves as a precaution however it is unknown if it pierced the skin." 03/26/2020- additional information received stated, "caregiver experienced a sharp sensation on her thumb.It was observed that there was a defect in the peel away sheath handle as a sharp piece of plastic was noted near the ¿bard¿ label." (b)(6) 2020- no prophylactic therapy was reported.
Event or Problem Description
It was reported "we had a dilator in the custom kit with sharp edges on it.When the inserter tried to break the dilator she was ¿poked¿ by something razor sharp.Upon assessment it was noticed that the dilator had a piece of plastic sticking straight up where the bard imprint is on the dilator.The inserter changed her gloves as a precaution however it is unknown if it pierced the skin." (b)(6) 2020- additional information received stated, "caregiver experienced a sharp sensation on her thumb.It was observed that there was a defect in the peel away sheath handle as a sharp piece of plastic was noted near the ¿bard¿ label." (b)(6) 2020- no prophylactic therapy was reported.
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 molding defect is confirmed and was determined to be manufacturing related.One half of a 4.5 fr microintroducer sheath was returned for evaluation.An initial visual observation showed no blood residue on the returned sample.Excess flash was observed protruding from the end of the t-handle near the bard logo.A microscopic observation revealed the flash on the t-handle was pointed but with a rounded tip.The flash was measured and was found to be approximately 0.04695 in.Long at its highest point.The investigation was forwarded to the manufacturing facility for further evaluation.Reynosa evaluation.Complaint due to ¿piece of plastic was noted near the bard logo¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual and measurement taken at vad lab the following was concluded: the excess of flash adhered on the t-handle was found to be out of specification per dwg & vs.A lack while removing flash was confirmed.Therefore, the cause of this condition is manufacturing related.As part of reinforcement about this issue, an awareness communication was provided to all personnel involved on this operation.A lot history review (lhr) of redv3533 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER, 4F SL, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9962606
• Report Number: 3006260740-2020-01307
• Device Sequence Number: 16840369
• Product Code: LJS
• UDI-Device Identifier: 00801741188060
• UDI-Public: (01)00801741188060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000775A
• Device Lot Number: REDV3533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR