MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported guide wire frayed thus making it impossible to pass the catheter.No other information was provided.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt4307 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported guide wire frayed thus making it impossible to pass the catheter.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), applicable manufacturing records, photo and video analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a frayed wire was confirmed but the cause is unknown.Two photographs and a video were returned for evaluation.What appeared to be a braided stylet wire was seen in the photos and video.Review of the damaged stylet revealed that the pull tab was missing from the wire.The wire was elongated and frayed with separation between the inner core wire and the outer coil wire.The wire contained multiple kinks and bends which may indicate difficult insertion or removal.This type of damage can occur if the wire fractures or is cut.Possible contributing factors could include difficult stylet removal due to not hydrating the hydrophilic coating, sharp instrument damage to the stylet and/or removing the stylet against resistance.H3 other text : evaluation findings are in section h.11.
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 broken stylet is confirmed.One 0.015 in.Stiffening stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The stylet was observed to be bent in many locations and the core wire of the stylet was observed to be broken with the majority of the coiled wire unraveled.The proximal end of the stylet was broken off and missing.A microscopic observation revealed the fracture site of the core wire to be angled, lustrous, and peaked, and linear striations were observed leading up to the peak of the break.The break site of the coiled wire was observed to be mostly flat and smooth.The observed characteristics of the break sites in the returned stylet are indicative of damage caused by a sharp instrument such as scissors.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported guide wire frayed thus making it impossible to pass the catheter.No other information was provided.

• Brand Name: PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13978905
• Report Number: 3006260740-2022-01099
• Device Sequence Number: 17650253
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2022

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 4134105
• Device Lot Number: REDT4307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 08/12/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/07/2022; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• 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 Age: 89 YR
• Patient Sex: Female