MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MYPICC KIT 4F SL TPS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number CK000451

Device Problems Activation Problem (4042); Fail-Safe Did Not Operate (4046)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "safety needle did not safety.Safety cover came off the needle and sharp was still exposed." additional information received (b)(6) 2021: access needle did not safety when removed form patient and needle was supposed to be protected with the safety crown.The safety crown came right off and did not have a stopping point.Additional information received (b)(6) 2021: placement info: the incident occurred during a usual and standard picc insertion with a cooperative patient.After use of the access needle, the needle was removed from the patient as is usual over the wire and without difficulty.The needle was then attempted to be placed in the safety position.During this usual step, the safety crown did not engage and slid completely off the needle without stopping.There was no resistance or catch noted, just a smooth removal of crown and my movement to engage was not forceful in any way.The needle was placed in a small hole in the picc tray for my safety during the rest of the procedure.Upon procedure completion, the needle housing was located and the needle carefully re-capped.

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, applicable previous investigation(s), labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached safety mechanism was confirmed but the cause is unknown.The product returned for evaluation was a 21 g x 2.75¿ secureloc echo introducer needle.The safety mechanism was returned completely detached from the introducer needle.The outer housing was opened by the investigator.Both the binding component and inner housing were present within the safety mechanism.Microscopic comparison was conducted on the complainant sample vs a non-complainant sample.The two inner housings and binding clips appeared similar.No defects were noted on the returned sample.The safety mechanism was threaded back onto the needle shaft by the investigator.When the holes on the binding component were aligned with each other, the safety mechanism traveled along the needle smoothly.When the holes were slightly askew with respect to each other, the safety mechanism would become stuck on the needle shaft.Although it could be confirmed that the safety mechanism had detached from the needle, the root cause could not be determined.Possible contributing factors could include excessive force engaging the safety mechanism, the binding component friction being too low, or the safety housing structure being inadequate.The manufacturing facility was notified of this complaint.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported "safety needle did not safety.Safety cover came off the needle and sharp was still exposed." additional information received (b)(6)2021: access needle did not safety when removed form patient and needle was supposed to be protected with the safety crown.The safety crown came right off and did not have a stopping point.Additional information received (b)(6) 2021: placement info: the incident occurred during a usual and standard picc insertion with a cooperative patient.After use of the access needle, the needle was removed from the patient as is usual over the wire and without difficulty.The needle was then attempted to be placed in the safety position.During this usual step, the safety crown did not engage and slid completely off the needle without stopping.There was no resistance or catch noted, just a smooth removal of crown and my movement to engage was not forceful in any way.The needle was placed in a small hole in the picc tray for my safety during the rest of the procedure.Upon procedure completion, the needle housing was located and the needle carefully re-capped.

• Brand Name: BARD MYPICC KIT 4F SL TPS
• Type of Device: 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: 11369307
• MDR Text Key: 239722057
• Report Number: 3006260740-2021-00453
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741104183
• UDI-Public: (01)00801741104183
• Combination Product (y/n): N
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

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
• Device Operator: Health Professional
• Device Model Number: CK000451
• Device Catalogue Number: CK000451
• Device Lot Number: 19LBR459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 70