MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SURESTEP FOLEY TRAY - LUBRI-SIL I.C. TEMP SENSING, 16 FR.; SURESTEP TRAY

Catalog Number A319516AM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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 complainant received a catheter kit that was supposed to contain a silicone catheter (b)(4); however, the kit contained a latex catheter (b)(4).The patient allegedly has a latex allergy and experienced a mild reaction to the latex catheter.The patient was evaluated by the hospital staff and appeared to be fine.The catheter was replaced with a silicone catheter.

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 complainant received a catheter kit that was supposed to contain a silicone catheter (119316m); however, the kit contained a latex catheter (129416m).The patient allegedly has a latex allergy and experienced a mild reaction to the latex catheter.The patient was evaluated by the hospital staff and appeared to be fine.The catheter was replaced with a silicone catheter.

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 complainant received a catheter kit that was supposed to contain a silicone catheter (119316m); however, the kit contained a latex catheter (129416m).The patient allegedly has a latex allergy and experienced a mild reaction to the latex catheter.The patient was evaluated by the hospital staff and appeared to be fine.The catheter was replaced with a silicone catheter.

Manufacturer Narrative

Received 1 opened and 1 unopened surestep foley tray with the original unit packaging.During the visual evaluation it was noted that a latex catheter was packaged in the tray.The labeling showed the product catalog number as a319516am, lot # ngaq4149 and the bar code label referenced product number a319416am, lot number ngaq4149.A comparative sample was returned for product a319516am, lot # ngaq1605 which showed a silicone catheter packaged in the tray.The reported issue was confirmed as manufacturing related for the opened sample only.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "- caution: this product contains natural rubber latex which may cause allergic reactions.Visually inspect the product for any imperfections or surface deterioration prior to use.If the package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and direction for use." (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.

Event Description

It was reported that the complainant received a catheter kit that was supposed to contain a silicone catheter ((b)(4)); however, the kit contained a latex catheter ((b)(4)).The patient allegedly has a latex allergy and experienced a mild reaction to the latex catheter.The patient was evaluated by the hospital staff and appeared to be fine.The catheter was replaced with a silicone catheter.

• Brand Name: SURESTEP FOLEY TRAY - LUBRI-SIL I.C. TEMP SENSING, 16 FR.
• Type of Device: SURESTEP TRAY
• 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: 5763338
• MDR Text Key: 49249565
• Report Number: 1018233-2016-00833
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2016

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 Expiration Date: 07/31/2018
• Device Catalogue Number: A319516AM
• Device Lot Number: NGAQ4149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2016; 08/17/2016; 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• 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