MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383028

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Pneumonia (2011)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that leakage occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter ((b)(6) translation), "the patient who was cough with no obvious reason since a half months ago, and he had gustiness bother cough with larynx phlegm, nasal congestion, and barking cough.The sign of cough was not crowing at the end of the echo, there was no short of breath, wheezing, no fever, headache, vomiting, fatigue, night sweats, and no rash.On (b)(6) 2019 the child came to our clinics, he had taken the chest is a piece of both lungs texture densification, both lungs howed a little light shadow, sharp on both sides of the rib diaphragmatic angle, heart shadow had no abnormal sign.Considering mycopneumonia, the patient was admitted to the one-step outpatient department for "bronchial pneumonia".Closed intravenous indwelling needle was used for infusion at 10:05 am, (b)(6) 2019.After completion, no abnormal usage was found.On (b)(6) 2019 at 0:10, the nurse was ready to give patients injections, she was goning to open the clamp to use disposable syringes 2 ml to withdraw of indwelling needle, it was unusual to take more air from the needle, then the nurse pulled out the indwelling needle immediately, gave patients stop bleeding action.After the bleeding was stopped, they used the new closed venous indwelling needle for puncturing.There was no sign of abnormal after the doctor's observing.A small amount of water was added to the sealed the needle in a disposable dispenser and air is injected with a disposable syringe, there was the bubble at the 3cm to the tip of the needle.".

Event Description

It was reported that leakage occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter (chinese translation), "the patient who was cough with no obvious reason since a half months ago, and he had gustiness bother cough with larynx phlegm, nasal congestion, and barking cough.The sign of cough was not crowing at the end of the echo, there was no short of breath, wheezing, no fever, headache, vomiting, fatigue, night sweats, and no rash.On (b)(6) 2019 the child came to our clinics, he had taken the chest is a piece of both lungs texture densification, both lungs howed a little light shadow, sharp on both sides of the rib diaphragmatic angle, heart shadow had no abnormal sign.Considering mycopneumonia, the patient was admitted to the one-step outpatient department for "bronchial pneumonia".Closed intravenous indwelling needle was used for infusion at 10:05 am, (b)(6) 2019.After completion, no abnormal usage was found.On (b)(6) 2019 at 0:10, the nurse was ready to give patients injections, she was goning to open the clamp to use disposable syringes 2 ml to withdraw of indwelling needle, it was unusual to take more air from the needle, then the nurse pulled out the indwelling needle immediately, gave patients stop bleeding action.After the bleeding was stopped, they used the new closed venous indwelling needle for puncturing.There was no sign of abnormal after the doctor's observing.A small amount of water was added to the sealed the needle in a disposable dispenser and air is injected with a disposable syringe, there was the bubble at the 3cm to the tip of the needle.".

Manufacturer Narrative

Photo or sample were not provided to aid in our quality engineer¿s investigation.With the lack of a sample, bd was unable to observe the failure mode.A retention sample was analyzed and no issue with the sample that could lead to the malfunction was observed.Master production records were reviewed for the lot number and no non-conformances were noted during the manufacturing of this lot.Our records indicate that the reviewed batch record passed all the in-process inspection.Only this complaint has been received for the reported defect and lot number.Bd will continue to track and trend for this failure mode.A possible root cause could not be determined at this time.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9377209
• MDR Text Key: 180207633
• Report Number: 3006948883-2019-00982
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: 383028
• Device Lot Number: 9106906
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other