MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
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 redr0331 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported mid segment of the picc from about 40 to 44cm had faded or absent cm marks.Picc appeared packaged as normal.There was no adherence to the package wall or any obvious catheter deformities.No leaks or bulging of catheter wall upon priming with normal saline.When trimming the line placer noticed that some of the measurement markings were faded or absent.This did not include the portion of catheter inserted into the patient and was merely trimmed off at the predetermined length for this patient.
Event or Problem Description
It was reported mid segment of the picc from about 40 to 44cm had faded or absent cm marks.Picc appeared packaged as normal.There was no adherence to the package wall or any obvious catheter deformities.No leaks or bulging of catheter wall upon priming with normal saline.When trimming the line placer noticed that some of the measurement markings were faded or absent.This did not include the portion of catheter inserted into the patient and was merely trimmed off at the predetermined length for this patient.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the depth markings appeared faded was confirmed; however, the exact cause could not be determined.One photograph of a catheter segment was provided for investigation.The physical sample, which resembled the item in the photo, was subsequently returned for investigation.The returned sample, which was 13.5cm in length, showed the 43 and 44 cm depth markers to be faintly visible.A portion of the 45cm and 47cm depth markers appeared partially faded.The printing of the 53 and 54 cm depth markers was incomplete but was legible.It is unknown if the printing was affected from handling or use.Even if the marks are faded or incomplete, as long as the marks and/or characters are legible, they are acceptable.The manufacturing facility was notified of the complaint.Reynosa evaluation: complaint due to ¿measurement markings were faded or absent¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and gross visual evaluation performed at vad lab the following was concluded: the picc catheter segment was found to be illegible in some dot marks.Damage during the manufacturing process may be a potential root cause/contributor to the observed printing issue.However, no findings from the dhr review indicated a manufacturing/processing related event.Possible contributions factors: risks of damage during packaging, storage conditions, clinical procedure, handling during catheter placement taking in consideration the condition of the received sample, etc.Were considered.Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown.A lot history review (lhr) of redr0331 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9857876
• Report Number: 3006260740-2020-00938
• Device Sequence Number: 2373111
• Product Code: LJS
• UDI-Device Identifier: 00801741034473
• UDI-Public: (01)00801741034473
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1175108
• Device Lot Number: REDR0331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1