MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS W/GUARDIVA, PROBE COVER & BELDAR NEEDLE GUIDES; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1174108D3
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
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 (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the ekg pad looked to be soiled upon opening the pack from the sterile picc kit.The device was not used on a patient.No other information was provided.
Event or Problem Description
It was reported the ekg pad looked to be soiled upon opening the pack from the sterile picc kit.The device was not used on a patient.No other information was provided.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of matter on the electrode was confirmed, but the source and composition of the material could not be verified from the photo that was returned for evaluation.The photo showed the packaging strip for the 3cg ecg electrodes.One of the gelled electrodes was found on the center slot of the packaging strip while the other two electrodes had been removed.Reddish material was seen on the electrode.One large dot of the material was seen halfway on the stainless-steel snap and half-way on the white label.In addition, lots of smaller flecks/dots of the material were seen on the white label.The photo did not provide evidence as to what the material was.The backside of the electrode was not shown.Possible contributing factors include corrosion of the electrodes or contamination after the kit had been opened.Because the kit had been opened, it cannot be concluded when the material was introduced onto the electrode.Manufacturing records were reviewed and no evidence was found that the failure mode reported in this complaint was caused by the manufacturing process.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the ekg pad looked to be soiled upon opening the pack from the sterile picc kit.The device was not used on a patient.No other information was provided.
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 initial complaint appeared to be a reportable occurrence.Upon review it was determined that a reportable event had not occurred.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS W/GUARDIVA, PROBE COVER & BELDAR NEEDLE GUIDES
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11474662
• Report Number: 3006260740-2021-00803
• Device Sequence Number: 3413383
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2021

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: 1174108D3
• Device Catalogue Number: 1174108D3
• Device Lot Number: REEW2953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/04/2021; 09/09/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/03/2021; 09/21/2021
• 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