MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS; STAND, INFUSION

Catalog Number PIC0222

Device Problems Loose or Intermittent Connection (1371); Misconnection (1399)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juet0947 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported that the locking part of the device does not stay locked and in some they will not lock at all.No other information was provided.

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 batch history, labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the statlock would not remain closed was confirmed but the cause is unknown.Four packages from fixed-post picc plus crescent statlock devices were returned.However, only two statlock devices were returned.One of the devices was received in an unopened package.The statlock appeared unremarkable to gross visual examination.The latch posts were present and appeared undamaged and unremarkable.When an attempt was made to close the doors on the sample, the doors closed and stayed latched per design.The other statlock was received in an open pouch.The liner had not been removed from the sample.Black marker was seen on the sample, around where the top left door latch should have been.However, the latch was not seen on the sample.All returned packaging pouches were examined to see if the latching post was returned.However, the latching post was not returned for evaluation.An attempt was made to latch the doors on the sample.The right door latched and stayed shut, per design.The left door could close but did not click shut, as the latch post was missing.The door would not stay shut without the latch post.Microscopic examination of the area that was missing the latch post revealed that the latch post likely broke off of the sample.The edge of the break site was angled with parallel striations aligned to one side.This indicates that a side load force was likely applied to the post, causing it to break.However, it could not be determined how or when the latching post had become broken.Possible contributing factors could include forces applied to the device during storage or use.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the locking part of the device does not stay locked and in some they will not lock at all.No other information was provided.

• Brand Name: STATLOCK PICC PLUS
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10833456
• MDR Text Key: 217443855
• Report Number: 3006260740-2020-20514
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIC0222
• Device Lot Number: JUET0947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other