MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "resident nurse goes up to the ward to check on patient and it was brought to his attention that one of the patient picc line clamp is 'cracked' ¿ only on one side of the affected clamp.Because of this crack they are not able to clamp the picc properly.The team has not decided what to do yet ¿ to leave the picc as it is since patient has the picc for about 4 months and use it for antibiotic and blood taking.It is dual lumen and the other lumen still functioning properly.They will also check when patient will complete the antibiotic treatment.If just a few weeks more they may just leave it as it is.They will monitor closely and act accordingly.Patient status/ intervention: patient is fine and still using the picc, the team is observing patient closely.".
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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 cracked clamp is confirmed; however, the exact cause is unknown.Two photographs of a powerpicc catheter were returned for evaluation.An initial visual observation of the photographs showed one side of the hinge of the pinch clamp of the purple lumen of the catheter was cracked and broken.No details of this break could be seen in the returned photographs.While the cause of the break in the pinch clamp of the catheter could not be determined from the returned photographs, possible causes include exposure to incompatible chemicals, material fatigue, and/or excessive closing force.
Event or Problem Description
It was reported that "resident nurse goes up to the ward to check on patient and it was brought to his attention that one of the patient picc line clamp is 'cracked' ¿ only on one side of the affected clamp.Because of this crack they are not able to clamp the picc properly.The team has not decided what to do yet ¿ to leave the picc as it is since patient has the picc for about 4 months and use it for antibiotic and blood taking.It is dual lumen and the other lumen still functioning properly.They will also check when patient will complete the antibiotic treatment.If just a few weeks more they may just leave it as it is.They will monitor closely and act accordingly.Patient status/ intervention: patient is fine and still using the picc, the team is observing patient closely.".

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15973280
• Report Number: 3006260740-2022-05689
• Device Sequence Number: 6103089
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2023

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 Model Number: N/A
• Device Catalogue Number: 3276135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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