MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT POWERPICC SHERLOCK 3CG (4F) (SINGLE-LUMEN) (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 19abt964 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the extension leg broke while inserted.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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged extension tube was confirmed and appeared to be related to the use of the device.One 4 fr sl powerpicc catheter was returned for investigation.An infusion cap was attached to the hub.Evidence of use was observed on the catheter.The catheter appeared to have been trimmed at the 5 cm depth marker.A diagonal split in the extension tubing was present 5 mm from the molded wing hub.Two photographs of a portion of 4fr s/l powerpicc catheter were also provided.The photo sample corresponds to the returned physical sample.A partially circumferential split was observed near the molded joint.Microscopic observation of the split surface revealed striation patterns on the extension tubing.The split edges were sharply defined.Based on the characteristics of the split, the extension tubing likely came into contact with a sharp instrument.The product instructions for use (ifu) precautions state, "avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.".
Event or Problem Description
It was reported that the extension leg broke while inserted.No other information was provided.

• Brand Name: BARD MYPICC KIT POWERPICC SHERLOCK 3CG (4F) (SINGLE-LUMEN) (TPS)
• 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: 8951044
• Report Number: 3006260740-2019-02563
• Device Sequence Number: 16930710
• Product Code: LJS
• UDI-Device Identifier: 00801741121203
• UDI-Public: (01)00801741121203
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/12/2019

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: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000606
• Device Lot Number: 19ABT964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1