MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000632B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2021
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 refn0893 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by health professional "we had an interesting event on (b)(6) 2021.One of our nurses was placing a picc and it didn¿t feel right.She attempted to remove it and it knotted inside of the patient.The patient had to be transferred to a larger hospital for picc removal.".
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 of a catheter knot is confirmed.One 5 fr dl powerpicc catheter was returned for evaluation.A completely formed knot was present in the catheter near the 43 cm depth marker.Blood residue was visible on the catheter surface and a statlock securement device was attached to the securement wing of the hub, which confirms the device was used.Microscopic observation of the knot revealed it to be tightly wound.The catheter wall thickness was measured at the distal end and was found to be within manufacturing specification.Based on the description of the reported event, possible contributing factors include repeated advancement and retraction against resistance leading to a knot formation.The insertion location and patient anatomy may have also been contributing factors.Since a knot was observed to have formed on the catheter, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by health professional "we had an interesting event on (b)(6) 2021.One of our nurses was placing a picc and it didn¿t feel right.She attempted to remove it and it knotted inside of the patient.The patient had to be transferred to a larger hospital for picc removal.".

• Brand Name: POWERPICC CATHETER WITH SHERLOCK
• 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
• MDR Report Key: 12456792
• Report Number: 3006260740-2021-03789
• Device Sequence Number: 11753395
• Product Code: LJS
• UDI-Device Identifier: 00801741143755
• UDI-Public: (01)00801741143755
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: REFN0893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR