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

Model Number	CK000632B
Health Effect - Clinical Code	No Information (3190)
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 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 a fly in the kit is inconclusive due to poor sample condition.Two photo samples of what appears to be a dark colored insect on mesh cloth were returned for investigation.The photos show the same insect from two different angles.Since the condition of the package prior to opening could not be verified, the complaint is inconclusive due to poor sample condition.A lot history review (lhr) of recr0843 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc kit was opened and there was a fly inside.It was not used.
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 a fly in the kit is confirmed but the source and location at which it was introduced remains unknown.One 5 fr dl powerpicc opened kit was returned for investigation.The tray and components were returned wrapped in a light blue cover.The cover was unwrapped and a fly was observed on the inside of the cover.Particulates from the fly were observed to be dispersed throughout the cover and the tray.The fly appeared to be dried out.Based on the description of the fly being found upon package opening and the condition of the fly being dried out within the drape, possible contributing factors include the fly being introduced during package assembly or after package opening.The complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of recr0843 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc kit was opened and there was a fly inside.It was not used.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (5F) (D
• 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: 7871027
• Report Number: 3006260740-2018-02427
• Device Sequence Number: 16177093
• Product Code: LJS
• UDI-Device Identifier: 00801741143755
• UDI-Public: (01)00801741143755
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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 Model Number: CK000632B
• Device Catalogue Number: CK000632B
• Device Lot Number: RECR0843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1