MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL® INFANT CATH KIT; INFANT CATHETER KIT

Catalog Number	0035630
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the tip of the infant catheter became knotted while inserted in the patient's urethra.The urologist was called to remove the catheter, which allegedly resulted in trauma to the patient's urethra.Per follow up with nurse manager (b)(6) via phone on (b)(6) 2018, the trauma to the patient's urethra involved self-limited bleeding.No medical treatment reported.Per additional information received via email on (b)(6) 2018 from (b)(6), the urologist gave the catheter a firm tug to remove it from the patient's urethra.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened, used infant catheter present.Only the catheter and the cap were returned, the vial was not included in the returned sample.Visual inspection of the catheter surface noted a knot at the catheter tip.Under microscopic evaluation, the second drain hole appeared distorted due to the knot.No functional evaluation was able to be performed due to the condition of the returned sample.The catheter tip was unraveled and the length of the drain eyes was measured (0.0660" and 0.0630") and found to be within specification (0.062" +/- 0.006").The width of the drain eyes was measured (0.0350" and 0.0390") and the second drain eye was found to be out of specification (0.030" +/- 0.007").The outer diameter of the tube was measured (0.0655") and found to be within specification (0.066" +/- 0.003").Upon unraveling, the tip of the catheter did not straighten or return to its correct shape.The distance of the drain eyes to the tip was unable to be measured, as the sample was returned with a knot in the tip, and the catheter material did not return to its original shape upon unraveling.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: "infant and pediatric cath kits caution: read all instructions prior to use.Indications: bladder catheterization is performed when a sterile urine sample is needed and a clean catch specimen cannot be obtained.Warnings: the catheter should never be forced if resistance is felt.Trauma to the bladder (false passage) can be prevented by adequately lubricating the catheter and stretching the penis to straighten the urethra.Sterile: sterile unless package is opened or damaged.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.".
Event or Problem Description
It was reported that the tip of the infant catheter became knotted while inserted in the patient's urethra.The urologist was called to remove the catheter, which allegedly resulted in trauma to the patient's urethra.Per follow up with nurse manager mandy allan via phone on (b)(6)2018 , the trauma to the patient's urethra involved self-limited bleeding.No medical treatment reported.Per additional information received via email on(b)(6)2018 from mandy allan, the urologist gave the catheter a firm tug to remove it from the patient's urethra.

• Brand Name: DAVOL® INFANT CATH KIT
• Common Device Name: INFANT CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7826037
• Report Number: 1018233-2018-03836
• Device Sequence Number: 1678497
• Product Code: FFH
• UDI-Device Identifier: 00801741045844
• UDI-Public: (01)00801741045844
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 02/28/2021
• Device Catalogue Number: 0035630
• Device Lot Number: NGCN1341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR