MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 2F INTERMEDIATE TRAY (SINGLE-LUMEN) (30 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4132000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recq0250 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during the installation of the catheter they noticed that after the length of 12cms the catheter couldn't advance more.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of difficult catheter insertion is confirmed and appears to be manufacturing related.One 2 fr perqcath catheter and tray kit components were returned for investigation.Use residue was present on the catheter and microintroducer.An irregularity was observed on the catheter surface approximately 12 cm from the distal end.Microscopic observation of the catheter revealed clear, elastic material to be surrounding the catheter.Tweezers were used to pull back a section of the material and it was observed to be well bonded to the catheter surface.The photos of the sample will be forwarded to the manufacturing facility for further evaluation.Reynosa evaluation: the complaint of ¿the catheter couldn't advance more¿ is confirmed.According to the visual evaluation the catheter revealed clear, elastic material to be surrounding the catheter.The cause of this condition is manufacturing related.A lot history review (lhr) of recq0250 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during the installation of the catheter they noticed that after the length of 12cms the catheter couldn't advance more.No other information was provided.

• Brand Name: PER-Q-CATH PLUS PICC 2F INTERMEDIATE TRAY (SINGLE-LUMEN) (30 CM)
• 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: 7835628
• Report Number: 3006260740-2018-02298
• Device Sequence Number: 2434471
• Product Code: LJS
• UDI-Device Identifier: 00801741035203
• UDI-Public: (01)00801741035203
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 12/31/2019
• Device Model Number: 4132000
• Device Catalogue Number: 4132000
• Device Lot Number: RECQ0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1