MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 TOOMEY IRRIGATION SYRINGE; TOOMEY SYRINGE

Catalog Number 0038460

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2016

Event Type  malfunction  

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 Description

It was reported that the toomey and the adaptor do not fit as they have in previous cases.It was alleged that there is a tighter fit and the adaptor does not spin around the toomey.The complainant has been using the toomey device to attach to a "wolf" resectoscope during transurethral resection of the prostate.

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.

Manufacturer Narrative

Received 3 unopened toomey syringes in the original unit packaging and 2 unused toomey syringes only.Per visual inspection, no obvious defects were noted with the returned samples.The following functional evaluation were performed: inflate balloon: take an in house catheter to inflate the balloon (10cc).Connect the luer adapter to syringe.Fill the syringe with 10cc of water.Proceed to inflate the balloon, with the syringe.Catheter irrigation: fill the syringe with 70cc of water.Take an in house catheter to be irrigated (70cc).Connect the toomey adapter to catheter.Proceed to irrigate the catheter with the syringe.During both tests no discrepancies were found.The adapters (luer and toomey) stayed attach to the syringe for all samples.Per dimensional evaluation, the samples were found within specifications: cm1687 toomey adapter (dwg049638): sample 1: inner diameter =0.464 in (specification is 0.460 in ± 0.005 in).Sample 2: inner diameter =0.465 in (specification is 0.460 in ± 0.005 in).Sample 3: inner diameter =0.465 in (specification is 0.460 in ± 0.005 in).Sample 4: inner diameter =0.463 in (specification is 0.460 in ± 0.005 in).Sample 5: inner diameter =0.465 in (specification is 0.460 in ± 0.005 in).Cm1942 syringe barrel (dwg570b): sample 1: upper o.D.= 0.4675 in (specification 0.472 in ± 0.005 in).Lower o.D.= 0.500 in (specification 0.504 in ± 0.005 in).Sample 2: upper o.D.= 0.471 in (specification 0.472 in ± 0.005 in).Lower o.D.= 0.500 in (specification 0.504 in ± 0.005 in).Sample 3: upper o.D.= 0.470 in (specification 0.472 in ± 0.005 in).Lower o.D.= 0.501 in (specification 0.504 in ± 0.005 in).Sample 4: upper o.D.= 0.468 in (specification 0.472 in ± 0.005 in).Lower o.D.= 0.504 in (specification 0.504 in ± 0.005 in).Sample 5: upper o.D.= 0.472 in (specification 0.472 in ± 0.005 in).Lower o.D.= 0.500 in (specification 0.504 in ± 0.005 in).The reported event was unconfirmed as the returned samples were found within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: "three syringe tips are intended for use as follows: integral toomey tip - resectoscope irrigation, catheter tip - for catheter irrigation, 1 luer adapter (for foley catheter inflation).Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge." (b)(4).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.

• Brand Name: TOOMEY IRRIGATION SYRINGE
• Type of Device: TOOMEY SYRINGE
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5619899
• MDR Text Key: 44729209
• Report Number: 1018233-2016-00541
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 0038460
• Device Lot Number: NGZL1987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1