MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SECURELOC SAFETY INTRODUCER NEEDLE 21GX2.75IN; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "we had a secureloc where the base of the locking system (green part) was not connected or damaged.There was no caregiver or patient harm as it was noticed immediately." no other information provided.Add info rcvd 07/06/2021: date of occurrence: 6/21/2021 placement info: attempted to utilize secureloc, proceduralist noticed the green part of the needle was damaged and had a broken piece.The needle was not used for the procedure.
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 that the cap was disconnected from the a secureloc safety mechanism housing was confirmed but the cause was unknown.One secureloc safety introducer needle was returned for evaluation.There were no visible signs of use on the safety introducer needle.The cap was disconnected from the distal end of the green safety mechanism housing, but the clips that hold the cap in place appeared undamaged.The safety mechanism housing had been advanced 4 mm from the distal end of the clear needle hub.The disconnected cap was able to be reconnected with the safety mechanism housing and was unable to be separated again.Once the two pieces of the green safety mechanism housing were connected, the safety mechanism was able to be activated and no functional damage was noted.Since the cap had separated from the safety mechanism housing, the complaint was confirmed; however the root cause of the complaint could not be determined and the sample analysis did not point to a specific root cause.A review of the manufacturing records showed no evidence that the reported event was caused by the manufacturing process.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "we had a secureloc where the base of the locking system (green part) was not connected or damaged.There was no caregiver or patient harm as it was noticed immediately." no other information provided.Add info rcvd 07/06/2021: date of occurrence: (b)(6) 2021.Placement info: attempted to utilize secureloc, proceduralist noticed the green part of the needle was damaged and had a broken piece.The needle was not used for the procedure.

• Brand Name: SECURELOC SAFETY INTRODUCER NEEDLE 21GX2.75IN
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12182732
• Report Number: 3006260740-2021-02802
• Device Sequence Number: 14624337
• Product Code: DYB
• UDI-Device Identifier: 00801741041716
• UDI-Public: (01)00801741041716
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050023
• 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): 08/23/2021

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: N/A
• Device Catalogue Number: S03021-275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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