MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	3175118
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer that the power picc catheter did not come with the markings every 1cm, at the height of the 32cm marking there is no marking, reappearing at the end of the catheter.There is no sample, due to the catheter being inserted in the patient.On 03/14/2023: additional information received.Missing catheter markings was noticed prior to use.No patient or caregiver harm.There was no need for medical and/or surgical intervention.
Event or Problem Description
It was reported by the customer that the power picc catheter did not come with the markings every 1cm, at the height of the 32cm marking there is no marking, reappearing at the end of the catheter.There is no sample, due to the catheter being inserted in the patient.(b)(6), 2023: additional information received.Missing catheter markings was noticed prior to use.No patient or caregiver harm.There was no need for medical and/or surgical intervention.
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 complaint of missing depth markings on the catheter was confirmed and appears to be related to the manufacturing process.A single photograph of a picc catheter was returned for evaluation.The proximal end of the device was not visible in the photograph, so the configuration could not be verified, but the sample appeared consistent with the implicated 5fr s/l powerpicc catheter.The catheter shaft appeared to be missing depth markings.The printing disappeared at the 33cm depth marking and then reappeared again near the distal end of the catheter.The exact number of depth markings missing from the catheter could not be determined from the photograph but appeared to be approximately 19 centimeters worth or printing.A review of the catheter drawing confirmed that the catheter shaft should contain continuous depth markings from 0cm through the 54cm marking dot.As the missing depth markings were noted prior to placement of the device, the most probable cause is due to the manufacturing printing process.Bd is working closely with manufacturing to help prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16660739
• Report Number: 3006260740-2023-01106
• Device Sequence Number: 1700341
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 03/31/2024
• Device Catalogue Number: 3175118
• Device Lot Number: REFR0427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 04/01/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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