MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE) TRAY

Catalog Number 907314

Device Problems Inadequate Instructions for Healthcare Professional (1319); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the catheter inside the packaging was allegedly a latex catheter and not a silicone catheter.The catheter packaging stated that the product did not contain latex, and was a silicone catheter.The staff was unaware that the catheter was a latex catheter and inserted it into the patient.The patent was allergic to latex, and the catheter was immediately removed after suspicions of it being a latex catheter.A new catheter from a new box that contained the same ref number and the same lot number was used.There was a difference with the catheters as one was brown and the other one was clear.Details of injury: there was no reaction at the time of insertion.The patient was monitored for any signs of an allergic reaction.

Event Description

It was reported that the catheter inside the packaging was allegedly a latex catheter and not a silicone catheter.The catheter packaging stated that the product did not contain latex, and was a silicone catheter.The staff was unaware that the catheter was a latex catheter and inserted it into the patient.The patent was allergic to latex, and the catheter was immediately removed after suspicions of it being a latex catheter.A new catheter from a new box that contained the same ref number and the same lot number was used.There was a difference with the catheters as one was brown and the other one was clear.Details of injury: there was no reaction at the time of insertion.The patient was monitored for any signs of an allergic reaction.

Manufacturer Narrative

The reported event was as confirmed manufacturing related as the incorrect component was preassembled.The device was used for treatment.The device did not meet specifications.The device was affected by the reported failure.Visual evaluation of the returned sample noted opened (original packaging) silicone foley tray.It was noted that there was a latex foley catheter within this tray, connected to a drain bag where the silicone foley should be with a seemingly intact tamper evident seal.This does not meet the specification that components are to be present, correct, undamaged, and approved by qa within the standard which corresponds to the correct catheter and sample port connector subassembly for the tray.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be not following procedure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿released pk7659069 07/2019 manufacturer: (b)(4).Statlock® foley catheter stabilisation device kit uro-prep® tray with: 2 - gloves (not made with natural rubber latex) 1 - fenestrated drape 5 - gauze squares (7.5 cm x 7.5 cm) 1 - underpad 1 - 10 ml syringe, filled with water soluble lubricating gel 1 - 10 ml syringe, filled with sterile water (only for inflating the catheter) 1 - 10 ml syringe, empty (only for deflating the catheter) 2 - 10 ml syringe, filled with sterile water (for cleansing purposes only) please see reverse side for directions for use single use only contains or presence of phthalates: di (2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.This is a single use device.Do not resterilise any portion of this device.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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws, regulations, and policies.Caution keep away from sunlight.Do not store at freezing temperatures, keep at room temperature away from direct exposure to light, preferably in original box.Consult instructions for use do not use if package is damaged.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Sterilized using ethylene oxide.Warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage the catheter and may cause balloon to burst.For urological use only.Inflate with 10 ml sterile water do not resterilise bd switzerland sàrl terre bonne park - a4 route de crassier 17 1262 eysins, switzerland 2797" correction: d1, d4, e4 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.

• Brand Name: BARD® FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE) TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9794969
• MDR Text Key: 185228687
• Report Number: 1018233-2020-01591
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

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: 06/30/2022
• Device Catalogue Number: 907314
• Device Lot Number: NGDT2571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1