MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the statlock cannot use.Patient status/intervention: fine.Add to description: 09/28/2022 - the stalock on the returned sample was observed to be detached from the pad.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged statlock device is confirmed and was determined to be manufacturing related.One picc plus statlock device with a foam pad and fixed posts was returned for evaluation.An initial visual observation showed a use residue on the returned sample.The retainer of the statlock device was observed to be completely detached from the pad.The detached retainer was returned stuck to the underside of the pad.Indentations were observed in the foam pad from where the retainer was originally attached, and a small amount of damage was observed in the foam pad in the upper portion of these indentations.A few small pieces of the foam pad were observed to be adhered to the upper portion of the underside of the retainer, aligning with the damaged portion of the pad.The underside of the retainer was observed to be tacky.Likely causes of the detached retainer include inadequate adhesive coverage, improper/incomplete cure of the adhesive, and/or an inadequate application of primer during manufacturing.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.

• Brand Name: 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15550404
• Report Number: 3006260740-2022-03905
• Device Sequence Number: 19528194
• Product Code: LJS
• UDI-Device Identifier: 00801741028014
• UDI-Public: (01)00801741028014
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

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: N/A
• Device Catalogue Number: 3276155
• Device Lot Number: REFS0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown