MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	2194108
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the picc line catheter for central venous use was used to deliver cytotoxic substances.Patient given piccline on (b)(6) 2023, laid on 4 cm, prior to chemotherapy treatment- cisplatin and with prehydration which is fine to give.Patient is with his doctor in the ward (b)(6) 2023 who sees after rearrangement of piccline.When flushing that it leaks.Sodium chloride in the newly applied dressing.The patient is asked to contact us.Patient calls and arrives.Nurse removes dressing.Puts compress under injection site and secura cath.Sees leakage.Piccline nurse is called.The lid of the securacath is lifted off.The piccline nurse pulls out the piccline a little at a time.After 1.5 cm a hole can be seen on the catheter, i.E.At 5.5 cm.A new catheter needs to be inserted.New access needed, extended waiting time.
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged catheter was confirmed and the cause appeared to be related to device use.The product returned for evaluation was one 4fr single lumen powerpicc solo catheter.Use residues were observed throughout the sample.A sharp permanent kink impression was observed near the 5cm depth marking.A longitudinally aligned split was observed at one corner of the kink.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a spraying leak was observed emanating from the split.The sample kinked preferentially at the kink site during manual manipulation.Microscopic inspection of the split revealed a granular fracture surface.Material wear and buckling were observed in the vicinity of the split.The split features and location were consistent with damaged caused by sharp kinking of the indwelling catheter shaft.The location of the damage suggested that catheter securement technique may have contributed.
Event or Problem Description
Customer reported that the picc line catheter for central venous use was used to deliver cytotoxic substances.Patient given piccline on (b)(6) 2023, laid on 4 cm, prior to chemotherapy treatment- cisplatin and with prehydration which is fine to give.Patient is with his doctor in the ward 2023-05-03- who sees after rearrangement of piccline- when flushing that it leaks.Sodium chloride in the newly applied dressing.The patient is asked to contact us.Patient calls and arrives - nurse removes dressing - puts compress under injection site and secura cath - sees leakage.Piccline nurse is called - the lid of the securacath is lifted off - the piccline nurse pulls out the piccline a little at a time - after 1.5 cm a hole can be seen on the catheter - i.E.At 5.5 cm.A new catheter needs to be inserted.New access needed, extended waiting time.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: 17055864
• Report Number: 3006260740-2023-02228
• Device Sequence Number: 12453178
• Product Code: LJS
• UDI-Device Identifier: 00889989030587
• UDI-Public: (01)00889989030587
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 09/30/2024
• Device Catalogue Number: 2194108
• Device Lot Number: REGX2976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: Male