MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST; STAND, INFUSION

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2020
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 judrf490 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that clip was not adhering to adhesive wings.It resulted in patient¿s picc to slip out of 0.2cm.
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, 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 detached retainer is confirmed and was determined to be manufacturing related.One picc plus statlock device with a tricot pad and fixed posts was returned for evaluation.An initial visual observation showed use residue on the returned sample.The retainer was observed to be completely detached from the pad of the device.A microscopic observation revealed poor adhesive coverage on the underside of the retainer, especially on sides and lower region of the retainer.The investigation was forwarded to the manufacturing facility for further evaluation.Awareness training was performed with the manufacturing operators regarding this complaint.A lot history review (lhr) of judrf490 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that clip was not adhering to adhesive wings.It resulted in patient¿s picc to slip out of 0.2cm.
Event or Problem Description
It was reported that clip was not adhering to adhesive wings.It resulted in patient¿s picc to slip out of 0.2cm.
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, 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 detached retainer is confirmed and was determined to be manufacturing related.One picc plus statlock device with a tricot pad and fixed posts was returned for evaluation.An initial visual observation showed use residue on the returned sample.The retainer was observed to be completely detached from the pad of the device.A microscopic observation revealed poor adhesive coverage on the underside of the retainer, especially on sides and lower region of the retainer.The investigation was forwarded to the manufacturing facility for further evaluation.Awareness training was performed with the manufacturing operators regarding this complaint.A lot history review (lhr) of judy0674 showed no other similar product complaint(s) from this lot number.

• Brand Name: STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10617401
• Report Number: 3006260740-2020-03417
• Device Sequence Number: 2578252
• Product Code: FOX
• UDI-Device Identifier: 00801741082962
• UDI-Public: (01)00801741082962
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2020

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: 03/28/2022
• Device Model Number: N/A
• Device Catalogue Number: PIC0222
• Device Lot Number: JUDY0674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 11/16/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/30/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1