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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)
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| Model Number 119314 |
| Device Problems
Deflation Problem (1149); Misassembled (1398); Difficult to Remove (1528)
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| Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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| Event Date 11/19/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that it was difficult to deflate a balloon during a pretest.
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Manufacturer Narrative
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The reported event was confirmed as manufacturing related.Visual evaluation of the returned sample noted one opened (without original packaging), 3-way temperature sensing silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Balloon concentricity was observed to be 50:50.The balloon rested for 30 minutes without leaks and was unable to be deflated.The catheter balloon was dissected to find that the inflation notch was not completely perforated.Silicone covered most of the hole.This is out of specification per inspection procedure which states, "verify that the eye punches are complete and notch according to the applicable drawing." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inadequate pressure on the machine to punch.¿ 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: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injuryed.] 2.Applicable patients patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse (2) do not resterilize (3) this device contains 10% povidine-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contract medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] directions for use: 1) clean the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." 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.
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Event Description
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It was reported that it was difficult to deflate a balloon during a pretest.
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| |
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Event Description
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It was reported that it was difficult to deflate a balloon during a pretest.
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| |
|
Manufacturer Narrative
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The reported event was confirmed as manufacturing related.Visual evaluation of the returned sample noted one opened (without original packaging), 3-way temperature sensing silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Balloon concentricity was observed to be 50:50.The balloon rested for 30 minutes without leaks and was unable to be deflated.The catheter balloon was dissected to find that the inflation notch was not completely perforated.Silicone covered most of the hole.This is out of specification per inspection procedure which states, "verify that the eye punches are complete and notch according to the applicable drawing." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inadequate pressure on the machine to punch.¿ 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: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injuryed.] 2.Applicable patients patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse (2) do not resterilize (3) this device contains 10% povidine-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contract medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] directions for use: 1) clean the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." 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.
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